<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03812640</url>
  </required_header>
  <id_info>
    <org_study_id>Vicryl Unicamp</org_study_id>
    <nct_id>NCT03812640</nct_id>
  </id_info>
  <brief_title>Nylon Verus Polyglactin Corneal Suture in Pediatric Cataract Surgery</brief_title>
  <official_title>Comparison Between Nylon and Polyglactin Corneal Suture in Pediatric Cataract Surgery: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pediatric cataract surgery requires the suturing of the corneal incision in order to maintain&#xD;
      the integrity of the eyeball and to help avoid the trauma often caused by scratching in the&#xD;
      postoperative period of pediatric surgeries. Traditionally, this suturing is performed using&#xD;
      10-0 nylon material. Because this material is non-absorbable, it must be removed under&#xD;
      sedation in cases of complications such as suture loosening, late suture lysis, accumulation&#xD;
      of secretion on the suture, corneal neovascularization, and corneal ulceration. The objetive&#xD;
      of this study is to compare the rate of postoperative complications and the need for suture&#xD;
      removal after pediatric cataract surgery in cases in which nylon (non-absorbable) sutures are&#xD;
      used versus cases in which polyglactin (absorbable) sutures are used.&#xD;
&#xD;
      This is a controlled, randomized, prospective, single-center study performed on patients&#xD;
      undergoing pediatric cataract surgery at the Clinical Hospital of the University of Campinas&#xD;
      (UNICAMP). The volunteers for whom cataract extraction surgery has been indicated and who&#xD;
      have signed the ICF (or whose ICF has been signed by a parent or guardian) will undergo&#xD;
      cataract surgery and the cornea will be sutured using a polyglactin 910 suture (Vicryl®&#xD;
      10-0). In the control group (Group B), the cornea will be sutured using nylon 10-0 sutures&#xD;
      (the current routine procedure). All patients will be monitored for six months and will&#xD;
      receive complete ophthalmological evaluations in order to determine whether they experience&#xD;
      any suture-related complications and whether sutures must be removed under sedation. A lower&#xD;
      incidence of complications and a less frequent need for suture removal under sedation are&#xD;
      expected in the group receiving Vicryl® sutures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are diagnosed with cataracts and for whom surgery is indicated shall be&#xD;
      evaluated (as much as possible based on their ability to cooperate with the assessment) in&#xD;
      terms of their visual acuity and refractive error via biomicroscopy, automated keratometry&#xD;
      (Auto Kerato Refractometer KR 8000® Alcon), Goldmann applanation tonometry, fundoscopy, and&#xD;
      biometric assessment (Ocuscan RxP® Alcon or Lenstar LS900® Haag-Streit International).&#xD;
&#xD;
      Patients who choose to sign (or whose guardians choose to sign) the informed consent form&#xD;
      after being informed of all of the aspects of the surgery and this trial shall be randomly&#xD;
      divided into one of two groups that shall be approximately equal in size and stratified by&#xD;
      age.&#xD;
&#xD;
        -  Up to 6 months of age&#xD;
&#xD;
        -  From 6 to 12 months of age&#xD;
&#xD;
        -  From 1 to 3 years of age&#xD;
&#xD;
        -  From 3 to 6 years of age&#xD;
&#xD;
        -  Older than 6 years Patients in Group A will have their surgical incisions sutured with&#xD;
           polyglactin 10-0 material (Vicryl®, composed of polyglactin 910, 10-0 diameter,&#xD;
           absorbable, a 0.62 cm, 3/8 circle needle) at the end of cataract surgery followed by the&#xD;
           use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied.&#xD;
           Patients in Group B will have their surgical incisions sutured with nylon 10-0 material&#xD;
           (Vicryl®, composed of nylon monofilament, 10-0 diameter, absorbable, a 0.55 cm, 1/2&#xD;
           circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin&#xD;
           and 0.1% dexamethasone eye drops before the bandage is applied.&#xD;
&#xD;
      Cataract surgery will be performed using the standardized protocol in the Ophthalmology&#xD;
      department of UNICAMP by fourth-year ophthalmology residents with experience in pediatric&#xD;
      cataract surgery. Preoperative pupil dilation shall be performed through the use of 2.5%&#xD;
      phenylephrine and 1% tropicamide 3 times in five-minute increments. General anesthesia shall&#xD;
      be performed. Skin sterilization shall be performed using an aqueous solution of 10%&#xD;
      povidone-iodine. After the sterile surgical field is established and the eyelashes are&#xD;
      isolated, 4 eye drops containing 5% povidone-iodine shall be administered in the conjunctival&#xD;
      sac with subsequent irrigation using a 10% balanced salt solution. In cases of allergy to&#xD;
      povidone-iodine, an aqueous solution of 0.05% chlorhexidine shall be used. The main incision&#xD;
      (either a clear corneal incision or a scleral tunnel) will be 2.2 mm to 3.0 mm, and&#xD;
      aspiration will be applied using the Infiniti® or Laureate® phacoemulsifier (Alcon) with a&#xD;
      foldable AcrySof® intraocular lens (Alcon) and a posterior capsulotomy with an automated&#xD;
      vitrectomy only in cases in which it is indicated.&#xD;
&#xD;
      Neither patients nor surgeons will be masked to the study treatment. The postoperative&#xD;
      consultations will be held on the first, seventh, thirtieth, ninetieth, one hundred and&#xD;
      twentieth, and one hundred and eightieth postoperative days and will include visual acuity&#xD;
      assessments, refractive error assessments, keratometry , biomicroscopy, applanation&#xD;
      tonometry, and fundoscopy, depending on the patient's age and ability to cooperate. If a&#xD;
      necessary exam is not possible in a clinical setting, it will be performed under sedation in&#xD;
      the surgical center.&#xD;
&#xD;
      Primary outcome: frequency of complications associated with sutures in each group.&#xD;
&#xD;
      Secondary outcome: need for suture removal under sedation in each group. The following will&#xD;
      be defined as suture-related complications: corneal neovascularization close to the suture,&#xD;
      loosening of the suture, accumulation of mucus on the suture, early rupture (within 2 weeks&#xD;
      or less) of the suture, aqueous humor leakage through the incision (as determined by the&#xD;
      Seidel test), prolapse of the iris through the incision site, infectious or traumatic&#xD;
      keratitis, endophthalmitis and giant papillary conjunctivitis as observed in a biomicroscopy&#xD;
      exam using a slit lamp.&#xD;
&#xD;
      Based on the frequency of suture-related complications described in the literature and using&#xD;
      a two-tailed 95% confidence interval, 80% power, an exposed/unexposed radius of 1, and a null&#xD;
      frequency of complications in the polyglactin suture group, approximately 40 subjects are&#xD;
      needed for each group. UNICAMP performs an average of 75 pediatric cataract surgeries per&#xD;
      year. Thus, there is a perspective for patient inclusion and study completion of just over&#xD;
      one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>frequency of complications associated with sutures in each group</measure>
    <time_frame>180 days</time_frame>
    <description>frequency of complications associated with sutures in each group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>need for suture removal under sedation in each group.</measure>
    <time_frame>180 days</time_frame>
    <description>need for suture removal under sedation in each group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Endophthalmitis</condition>
  <condition>Cataracts Infantile</condition>
  <condition>Suture, Complication</condition>
  <arm_group>
    <arm_group_label>Vicryl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vicryl suture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nylon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nylon suture</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vicryl suture</intervention_name>
    <description>Corneal suture with Vicryl suture</description>
    <arm_group_label>Vicryl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nylon suture</intervention_name>
    <description>Corneal suture with Nylon suture</description>
    <arm_group_label>Nylon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients up to 14 years of age who are clinically qualified to undergo pediatric&#xD;
             cataract surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic cataract with ocular perforation&#xD;
&#xD;
          -  Cataract surgery associated with other procedures, such as glaucoma filtering surgery,&#xD;
             vitreoretinal surgery, and cornea surgery&#xD;
&#xD;
          -  Signs of ocular or periocular infection&#xD;
&#xD;
          -  Advanced glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Days</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mathias Melega, MD</last_name>
    <phone>+55 19 997513150</phone>
    <email>mvmelega@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mathias Violante Mélega</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13025-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathias V Mélega</last_name>
      <phone>19997513150</phone>
      <email>mvmelega@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Foster A, Gilbert C, Rahi J. Epidemiology of cataract in childhood: a global perspective. J Cataract Refract Surg. 1997;23 Suppl 1:601-4. doi: 10.1016/s0886-3350(97)80040-5.</citation>
    <PMID>9278811</PMID>
  </reference>
  <reference>
    <citation>Gilbert CE, Wood M, Waddel K, Foster A. Causes of childhood blindness in east Africa: results in 491 pupils attending 17 schools for the blind in Malawi, Kenya and Uganda. Ophthalmic Epidemiol. 1995 Jun;2(2):77-84. doi: 10.3109/09286589509057086.</citation>
    <PMID>7585238</PMID>
  </reference>
  <reference>
    <citation>Haargaard B, Wohlfahrt J, Fledelius HC, Rosenberg T, Melbye M. Incidence and cumulative risk of childhood cataract in a cohort of 2.6 million Danish children. Invest Ophthalmol Vis Sci. 2004 May;45(5):1316-20. doi: 10.1167/iovs.03-0635.</citation>
    <PMID>15111583</PMID>
  </reference>
  <reference>
    <citation>WHO | Priority eye diseases. WHO [Internet]. 2014 [cited 2017 Dec 29]; Available from: http://www.who.int/blindness/causes/priority/en/index3.html</citation>
  </reference>
  <reference>
    <citation>Wilson BME. Pediatric Cataracts : Overview Classification ( Categorization ). 2016;</citation>
  </reference>
  <reference>
    <citation>Heaven CJ, Boase DL. Suppurative keratitis with endophthalmitis due to biodegraded full thickness monofilament nylon corneal sutures. Eur J Implant Refract Surg [Internet]. 1993;5(3):164-8. Available from: http://dx.doi.org/10.1016/S0955-3681(13)80436-4</citation>
  </reference>
  <reference>
    <citation>Lee BJ, Smith SD, Jeng BH. Suture-related corneal infections after clear corneal cataract surgery. J Cataract Refract Surg. 2009 May;35(5):939-42. doi: 10.1016/j.jcrs.2008.10.061.</citation>
    <PMID>19393897</PMID>
  </reference>
  <reference>
    <citation>Culbert RB, Devenyi RG. Bacterial endophthalmitis after suture removal. J Cataract Refract Surg. 1999 May;25(5):725-7. doi: 10.1016/s0886-3350(99)00020-6.</citation>
    <PMID>10330655</PMID>
  </reference>
  <reference>
    <citation>Khurshid GS, Fahy GT. Endophthalmitis secondary to corneal sutures: series of delayed-onset keratitis requiring intravitreal antibiotics. J Cataract Refract Surg. 2003 Jul;29(7):1370-2. doi: 10.1016/s0886-3350(03)00404-8.</citation>
    <PMID>12900247</PMID>
  </reference>
  <reference>
    <citation>Acheson JF, Lyons CJ. Ocular morbidity due to monofilament nylon corneal sutures. Eye (Lond). 1991;5 ( Pt 1):106-12. doi: 10.1038/eye.1991.20. No abstract available.</citation>
    <PMID>2060657</PMID>
  </reference>
  <reference>
    <citation>Danjoux JP, Reck AC, to C. CORNEAL SUTURES: IS ROUTINE REMOVAL REALLY NECESSARY? [cited 2017 Dec 28]; Available from: https://www.nature.com/articles/eye199470.pdf</citation>
  </reference>
  <reference>
    <citation>Bainbridge JW, Teimory M, Kirwan JF, Rostron CK. A prospective controlled study of a 10/0 absorbable polyglactin suture for corneal incision phacoemulsification. Eye (Lond). 1998;12 ( Pt 3a):399-402. doi: 10.1038/eye.1998.94.</citation>
    <PMID>9775239</PMID>
  </reference>
  <reference>
    <citation>Bar-Sela SM, Spierer O, Spierer A. Suture-related complications after congenital cataract surgery: Vicryl versus Mersilene sutures. J Cataract Refract Surg. 2007 Feb;33(2):301-4. doi: 10.1016/j.jcrs.2006.10.039.</citation>
    <PMID>17276274</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Mathias Violante Mélega</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>cataract</keyword>
  <keyword>suture</keyword>
  <keyword>poliglactin</keyword>
  <keyword>nylon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endophthalmitis</mesh_term>
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03812640
org study id: Vicryl Unicamp
nct id: NCT03812640
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pediatric cataract surgery requires the suturing of the corneal incision in order to maintain
      the integrity of the eyeball and to help avoid the trauma often caused by scratching in the
      postoperative period of pediatric surgeries. Traditionally, this suturing is performed using
      10-0 nylon material. Because this material is non-absorbable, it must be removed under
      sedation in cases of complications such as suture loosening, late suture lysis, accumulation
      of secretion on the suture, corneal neovascularization, and corneal ulceration. The objetive
      of this study is to compare the rate of postoperative complications and the need for suture
      removal after pediatric cataract surgery in cases in which nylon (non-absorbable) sutures are
      used versus cases in which polyglactin (absorbable) sutures are used.

      This is a controlled, randomized, prospective, single-center study performed on patients
      undergoing pediatric cataract surgery at the Clinical Hospital of the University of Campinas
      (UNICAMP). The volunteers for whom cataract extraction surgery has been indicated and who
      have signed the ICF (or whose ICF has been signed by a parent or guardian) will undergo
      cataract surgery and the cornea will be sutured using a polyglactin 910 suture (Vicryl®
      10-0). In the control group (Group B), the cornea will be sutured using nylon 10-0 sutures
      (the current routine procedure). All patients will be monitored for six months and will
      receive complete ophthalmological evaluations in order to determine whether they experience
      any suture-related complications and whether sutures must be removed under sedation. A lower
      incidence of complications and a less frequent need for suture removal under sedation are
      expected in the group receiving Vicryl® sutures.
Patients who are diagnosed with cataracts and for whom surgery is indicated shall be
      evaluated (as much as possible based on their ability to cooperate with the assessment) in
      terms of their visual acuity and refractive error via biomicroscopy, automated keratometry
      (Auto Kerato Refractometer KR 8000® Alcon), Goldmann applanation tonometry, fundoscopy, and
      biometric assessment (Ocuscan RxP® Alcon or Lenstar LS900® Haag-Streit International).

      Patients who choose to sign (or whose guardians choose to sign) the informed consent form
      after being informed of all of the aspects of the surgery and this trial shall be randomly
      divided into one of two groups that shall be approximately equal in size and stratified by
      age.

        -  Up to 6 months of age

        -  From 6 to 12 months of age

        -  From 1 to 3 years of age

        -  From 3 to 6 years of age

        -  Older than 6 years Patients in Group A will have their surgical incisions sutured with
           polyglactin 10-0 material (Vicryl®, composed of polyglactin 910, 10-0 diameter,
           absorbable, a 0.62 cm, 3/8 circle needle) at the end of cataract surgery followed by the
           use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied.
           Patients in Group B will have their surgical incisions sutured with nylon 10-0 material
           (Vicryl®, composed of nylon monofilament, 10-0 diameter, absorbable, a 0.55 cm, 1/2
           circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin
           and 0.1% dexamethasone eye drops before the bandage is applied.

      Cataract surgery will be performed using the standardized protocol in the Ophthalmology
      department of UNICAMP by fourth-year ophthalmology residents with experience in pediatric
      cataract surgery. Preoperative pupil dilation shall be performed through the use of 2.5%
      phenylephrine and 1% tropicamide 3 times in five-minute increments. General anesthesia shall
      be performed. Skin sterilization shall be performed using an aqueous solution of 10%
      povidone-iodine. After the sterile surgical field is established and the eyelashes are
      isolated, 4 eye drops containing 5% povidone-iodine shall be administered in the conjunctival
      sac with subsequent irrigation using a 10% balanced salt solution. In cases of allergy to
      povidone-iodine, an aqueous solution of 0.05% chlorhexidine shall be used. The main incision
      (either a clear corneal incision or a scleral tunnel) will be 2.2 mm to 3.0 mm, and
      aspiration will be applied using the Infiniti® or Laureate® phacoemulsifier (Alcon) with a
      foldable AcrySof® intraocular lens (Alcon) and a posterior capsulotomy with an automated
      vitrectomy only in cases in which it is indicated.

      Neither patients nor surgeons will be masked to the study treatment. The postoperative
      consultations will be held on the first, seventh, thirtieth, ninetieth, one hundred and
      twentieth, and one hundred and eightieth postoperative days and will include visual acuity
      assessments, refractive error assessments, keratometry , biomicroscopy, applanation
      tonometry, and fundoscopy, depending on the patient's age and ability to cooperate. If a
      necessary exam is not possible in a clinical setting, it will be performed under sedation in
      the surgical center.

      Primary outcome: frequency of complications associated with sutures in each group.

      Secondary outcome: need for suture removal under sedation in each group. The following will
      be defined as suture-related complications: corneal neovascularization close to the suture,
      loosening of the suture, accumulation of mucus on the suture, early rupture (within 2 weeks
      or less) of the suture, aqueous humor leakage through the incision (as determined by the
      Seidel test), prolapse of the iris through the incision site, infectious or traumatic
      keratitis, endophthalmitis and giant papillary conjunctivitis as observed in a biomicroscopy
      exam using a slit lamp.

      Based on the frequency of suture-related complications described in the literature and using
      a two-tailed 95% confidence interval, 80% power, an exposed/unexposed radius of 1, and a null
      frequency of complications in the polyglactin suture group, approximately 40 subjects are
      needed for each group. UNICAMP performs an average of 75 pediatric cataract surgeries per
      year. Thus, there is a perspective for patient inclusion and study completion of just over
      one year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: frequency of complications associated with sutures in each group
time frame: 180 days
description: frequency of complications associated with sutures in each group
measure: need for suture removal under sedation in each group.
time frame: 180 days
description: need for suture removal under sedation in each group.
arm group label: Vicryl
arm group type: Experimental
description: Vicryl suture
arm group label: Nylon
arm group type: Active Comparator
description: Nylon suture
intervention type: Device
intervention name: Vicryl suture
description: Corneal suture with Vicryl suture
arm group label: Vicryl
intervention type: Device
intervention name: Nylon suture
description: Corneal suture with Nylon suture
arm group label: Nylon
criteria: 
gender: All
minimum age: 30 Days
maximum age: 14 Years
healthy volunteers: No
last name: Mathias Melega, MD
phone: +55 19 997513150
email: mvmelega@hotmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
citation: Foster A, Gilbert C, Rahi J. Epidemiology of cataract in childhood: a global perspective. J Cataract Refract Surg. 1997;23 Suppl 1:601-4. doi: 10.1016/s0886-3350(97)80040-5.
PMID: 9278811
citation: Gilbert CE, Wood M, Waddel K, Foster A. Causes of childhood blindness in east Africa: results in 491 pupils attending 17 schools for the blind in Malawi, Kenya and Uganda. Ophthalmic Epidemiol. 1995 Jun;2(2):77-84. doi: 10.3109/09286589509057086.
PMID: 7585238
citation: Haargaard B, Wohlfahrt J, Fledelius HC, Rosenberg T, Melbye M. Incidence and cumulative risk of childhood cataract in a cohort of 2.6 million Danish children. Invest Ophthalmol Vis Sci. 2004 May;45(5):1316-20. doi: 10.1167/iovs.03-0635.
PMID: 15111583
citation: WHO | Priority eye diseases. WHO [Internet]. 2014 [cited 2017 Dec 29]; Available from: http://www.who.int/blindness/causes/priority/en/index3.html
citation: Wilson BME. Pediatric Cataracts : Overview Classification ( Categorization ). 2016;
citation: Heaven CJ, Boase DL. Suppurative keratitis with endophthalmitis due to biodegraded full thickness monofilament nylon corneal sutures. Eur J Implant Refract Surg [Internet]. 1993;5(3):164-8. Available from: http://dx.doi.org/10.1016/S0955-3681(13)80436-4
citation: Lee BJ, Smith SD, Jeng BH. Suture-related corneal infections after clear corneal cataract surgery. J Cataract Refract Surg. 2009 May;35(5):939-42. doi: 10.1016/j.jcrs.2008.10.061.
PMID: 19393897
citation: Culbert RB, Devenyi RG. Bacterial endophthalmitis after suture removal. J Cataract Refract Surg. 1999 May;25(5):725-7. doi: 10.1016/s0886-3350(99)00020-6.
PMID: 10330655
citation: Khurshid GS, Fahy GT. Endophthalmitis secondary to corneal sutures: series of delayed-onset keratitis requiring intravitreal antibiotics. J Cataract Refract Surg. 2003 Jul;29(7):1370-2. doi: 10.1016/s0886-3350(03)00404-8.
PMID: 12900247
citation: Acheson JF, Lyons CJ. Ocular morbidity due to monofilament nylon corneal sutures. Eye (Lond). 1991;5 ( Pt 1):106-12. doi: 10.1038/eye.1991.20. No abstract available.
PMID: 2060657
citation: Danjoux JP, Reck AC, to C. CORNEAL SUTURES: IS ROUTINE REMOVAL REALLY NECESSARY? [cited 2017 Dec 28]; Available from: https://www.nature.com/articles/eye199470.pdf
citation: Bainbridge JW, Teimory M, Kirwan JF, Rostron CK. A prospective controlled study of a 10/0 absorbable polyglactin suture for corneal incision phacoemulsification. Eye (Lond). 1998;12 ( Pt 3a):399-402. doi: 10.1038/eye.1998.94.
PMID: 9775239
citation: Bar-Sela SM, Spierer O, Spierer A. Suture-related complications after congenital cataract surgery: Vicryl versus Mersilene sutures. J Cataract Refract Surg. 2007 Feb;33(2):301-4. doi: 10.1016/j.jcrs.2006.10.039.
PMID: 17276274
responsible party type: Principal Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Mathias Violante Mélega
investigator title: MD
mesh term: Endophthalmitis
mesh term: Cataract
sharing ipd: No