<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/NCT03001401</url>
  </required_header>
  <id_info>
    <org_study_id>C/2016/09/07</org_study_id>
    <nct_id>NCT03001401</nct_id>
  </id_info>
  <brief_title>Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE</brief_title>
  <official_title>Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Narayana Nethralaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Narayana Nethralaya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical&#xD;
      changes and inflammatory profile of normal eyes (matched for age, refraction and corneal&#xD;
      thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver&#xD;
      equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for&#xD;
      higher order aberrations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      iDesign is a promising new technique to treat myopia with astigmatism using ocular&#xD;
      aberrations measured with a high resolution wavefront sensor.[1,2] Early studies with iDesign&#xD;
      platform has established its safety and efficacy in correction of myopia with fewer patients&#xD;
      reporting night vision problems.[1,2] In keratoconus, iDesign has also provided excellent&#xD;
      outcomes following collagen crosslinking.3 SMILE is a recent technique that eliminates&#xD;
      creation of flap and appears to achieve similar refractive outcomes as conventional LASIK but&#xD;
      with less dryness, less inflammation and faster wound healing.[4,5] SMILE corrects lower&#xD;
      order aberrations only.[4,5] Thus, a comparative assessment of iDesign and SMILE is necessary&#xD;
      since iDesign can potentially give better visual outcomes with lower volume of tissue&#xD;
      removal. If lower volume of tissue is removed, it is also hypothesized that the corneal would&#xD;
      be more stable biomechanically.[5] Further, SMILE does not provide any correction of higher&#xD;
      order aberrations. With the inclusion of higher order aberrations in the iDesign treatment&#xD;
      plan, it is hypothesized that both short and long term outcomes will be better with iDesign&#xD;
      than with SMILE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual acuity measured as Logarithm of manifest refraction</measure>
    <time_frame>Post surgery over a period of 1 year</time_frame>
    <description>Uncorrected and corrected distance visual acuity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Corneal curvature in Diopter</measure>
    <time_frame>Post surgery over a period of 1 year</time_frame>
    <description>Optical coherence tomography and Scheimpflug imaging of the cornea will be performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in deformation of the cornea</measure>
    <time_frame>Post surgery over a period of 1 year</time_frame>
    <description>Air-puff applanation of the cornea will be used to asses deformation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ocular surface dryness and/or pain</measure>
    <time_frame>Post surgery over a period of 1 year</time_frame>
    <description>Assessed by ocular surface discomfort score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in wavefront aberrations described by Zernike Polynomials</measure>
    <time_frame>Post surgery over a period of 1 year</time_frame>
    <description>Corneal and ocular aberrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>iDesign</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMILE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iDesign</intervention_name>
    <description>One group will under go standard LASIK using iDesign platform (J&amp;J, USA). Visual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.</description>
    <arm_group_label>iDesign</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMILE</intervention_name>
    <description>The other group will undergo SMILE for treatment refractive error (Carl Zeiss, Germany). isual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.</description>
    <arm_group_label>SMILE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients should be between 18 to 50 years of age.&#xD;
&#xD;
          2. Patient must have stable myopia for a minimum period of one year (a change of 0.25D or&#xD;
             less) as documented by prior clinical records or current spectacle correction.&#xD;
&#xD;
          3. Patient must have a corrected distance visual acuity (CDVA) of 20/25 or better,&#xD;
&#xD;
          4. Patient must have a spherical equivalent refraction less than -10D&#xD;
&#xD;
          5. Patient must have refractive astigmatism less than 3D.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient must not have a central corneal thickness (CCT) less than 480 micrometer&#xD;
&#xD;
          2. Patient must not have a calculated residual stromal bed thickness of less than 250&#xD;
             micrometer after the surgery&#xD;
&#xD;
          3. Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular&#xD;
             disease, pregnancy, breastfeeding and any prior ocular surgery.&#xD;
&#xD;
          4. Patient must not have an inter-ocular difference of more than 1.00 diopter (D) of&#xD;
             spherical or 0.50 D of cylindrical refractive error.&#xD;
&#xD;
          5. Patient must not be on chronic systemic steroids or other medication that can affect&#xD;
             wound healing.&#xD;
&#xD;
          6. Patient must not be allergic to primary or alternative medications.&#xD;
&#xD;
          7. Patient must not be using rigid contact lenses for the last three weeks or soft&#xD;
             contact lenses for at least 1 week before the preoperative evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rohit Shetty, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Narayana Nethralaya</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abhijit Sinha Roy, PhD</last_name>
    <phone>+919740566833</phone>
    <email>asroy27@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Narayana Nethralaya</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560010</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rohit Shetty, MD, PhD</last_name>
      <phone>+919611102568</phone>
      <email>drrohitshetty@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Outcomes of wavefront-guided laser in situ keratomileusis using a new-generation Hartmann-Shack aberrometer in patients with high myopia. J Cataract Refract Surg. 2015 Sep;41(9):1810-9. doi: 10.1016/j.jcrs.2015.10.007.</citation>
    <PMID>26603388</PMID>
  </reference>
  <reference>
    <citation>Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Wavefront-Guided Photorefractive Keratectomy with the Use of a New Hartmann-Shack Aberrometer in Patients with Myopia and Compound Myopic Astigmatism. J Ophthalmol. 2015;2015:514837. doi: 10.1155/2015/514837. Epub 2015 Oct 4.</citation>
    <PMID>26504595</PMID>
  </reference>
  <reference>
    <citation>Shaheen MS, Shalaby Bardan A, Pinero DP, Ezzeldin H, El-Kateb M, Helaly H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a High-Resolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus. Cornea. 2016 Jul;35(7):946-53. doi: 10.1097/ICO.0000000000000888.</citation>
    <PMID>27191671</PMID>
  </reference>
  <reference>
    <citation>Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK. Ophthalmology. 2015 Apr;122(4):669-76. doi: 10.1016/j.ophtha.2014.10.004. Epub 2014 Nov 22.</citation>
    <PMID>25458707</PMID>
  </reference>
  <reference>
    <citation>Reinstein DZ, Archer TJ, Gobbe M. Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes. Eye Vis (Lond). 2014 Oct 16;1:3. doi: 10.1186/s40662-014-0003-1. eCollection 2014.</citation>
    <PMID>26605350</PMID>
  </reference>
  <reference>
    <citation>McNabb RP, Farsiu S, Stinnett SS, Izatt JA, Kuo AN. Optical coherence tomography accurately measures corneal power change from laser refractive surgery. Ophthalmology. 2015 Apr;122(4):677-86. doi: 10.1016/j.ophtha.2014.10.003. Epub 2014 Dec 6.</citation>
    <PMID>25487424</PMID>
  </reference>
  <reference>
    <citation>Matalia J, Francis M, Tejwani S, Dudeja G, Rajappa N, Sinha Roy A. Role of Age and Myopia in Simultaneous Assessment of Corneal and Extraocular Tissue Stiffness by Air-Puff Applanation. J Refract Surg. 2016 Jul 1;32(7):486-93. doi: 10.3928/1081597X-20160512-02.</citation>
    <PMID>27400081</PMID>
  </reference>
  <reference>
    <citation>Sinha Roy A, Kurian M, Matalia H, Shetty R. Air-puff associated quantification of non-linear biomechanical properties of the human cornea in vivo. J Mech Behav Biomed Mater. 2015 Aug;48:173-182. doi: 10.1016/j.jmbbm.2015.04.010. Epub 2015 Apr 20.</citation>
    <PMID>25955559</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Narayana Nethralaya</investigator_affiliation>
    <investigator_full_name>Dr Rohit Shetty</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT03001401
org study id: C/2016/09/07
nct id: NCT03001401
lead sponsor: 
has dmc: Yes
The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical
      changes and inflammatory profile of normal eyes (matched for age, refraction and corneal
      thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver
      equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for
      higher order aberrations.
iDesign is a promising new technique to treat myopia with astigmatism using ocular
      aberrations measured with a high resolution wavefront sensor.[1,2] Early studies with iDesign
      platform has established its safety and efficacy in correction of myopia with fewer patients
      reporting night vision problems.[1,2] In keratoconus, iDesign has also provided excellent
      outcomes following collagen crosslinking.3 SMILE is a recent technique that eliminates
      creation of flap and appears to achieve similar refractive outcomes as conventional LASIK but
      with less dryness, less inflammation and faster wound healing.[4,5] SMILE corrects lower
      order aberrations only.[4,5] Thus, a comparative assessment of iDesign and SMILE is necessary
      since iDesign can potentially give better visual outcomes with lower volume of tissue
      removal. If lower volume of tissue is removed, it is also hypothesized that the corneal would
      be more stable biomechanically.[5] Further, SMILE does not provide any correction of higher
      order aberrations. With the inclusion of higher order aberrations in the iDesign treatment
      plan, it is hypothesized that both short and long term outcomes will be better with iDesign
      than with SMILE.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in visual acuity measured as Logarithm of manifest refraction
time frame: Post surgery over a period of 1 year
description: Uncorrected and corrected distance visual acuity
measure: Change in Corneal curvature in Diopter
time frame: Post surgery over a period of 1 year
description: Optical coherence tomography and Scheimpflug imaging of the cornea will be performed
measure: Change in deformation of the cornea
time frame: Post surgery over a period of 1 year
description: Air-puff applanation of the cornea will be used to asses deformation
measure: Change in ocular surface dryness and/or pain
time frame: Post surgery over a period of 1 year
description: Assessed by ocular surface discomfort score
measure: Change in wavefront aberrations described by Zernike Polynomials
time frame: Post surgery over a period of 1 year
description: Corneal and ocular aberrations
arm group label: iDesign
arm group type: Active Comparator
description: Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power
arm group label: SMILE
arm group type: Active Comparator
description: Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power
intervention type: Other
intervention name: iDesign
description: One group will under go standard LASIK using iDesign platform (J&J, USA). Visual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.
arm group label: iDesign
intervention type: Other
intervention name: SMILE
description: The other group will undergo SMILE for treatment refractive error (Carl Zeiss, Germany). isual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.
arm group label: SMILE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rohit Shetty, MD, PHD
role: Principal Investigator
affiliation: Narayana Nethralaya
last name: Abhijit Sinha Roy, PhD
phone: +919740566833
email: asroy27@yahoo.com
facility: 
status: Recruiting
contact: 
country: India
citation: Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Outcomes of wavefront-guided laser in situ keratomileusis using a new-generation Hartmann-Shack aberrometer in patients with high myopia. J Cataract Refract Surg. 2015 Sep;41(9):1810-9. doi: 10.1016/j.jcrs.2015.10.007.
PMID: 26603388
citation: Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Wavefront-Guided Photorefractive Keratectomy with the Use of a New Hartmann-Shack Aberrometer in Patients with Myopia and Compound Myopic Astigmatism. J Ophthalmol. 2015;2015:514837. doi: 10.1155/2015/514837. Epub 2015 Oct 4.
PMID: 26504595
citation: Shaheen MS, Shalaby Bardan A, Pinero DP, Ezzeldin H, El-Kateb M, Helaly H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a High-Resolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus. Cornea. 2016 Jul;35(7):946-53. doi: 10.1097/ICO.0000000000000888.
PMID: 27191671
citation: Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK. Ophthalmology. 2015 Apr;122(4):669-76. doi: 10.1016/j.ophtha.2014.10.004. Epub 2014 Nov 22.
PMID: 25458707
citation: Reinstein DZ, Archer TJ, Gobbe M. Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes. Eye Vis (Lond). 2014 Oct 16;1:3. doi: 10.1186/s40662-014-0003-1. eCollection 2014.
PMID: 26605350
citation: McNabb RP, Farsiu S, Stinnett SS, Izatt JA, Kuo AN. Optical coherence tomography accurately measures corneal power change from laser refractive surgery. Ophthalmology. 2015 Apr;122(4):677-86. doi: 10.1016/j.ophtha.2014.10.003. Epub 2014 Dec 6.
PMID: 25487424
citation: Matalia J, Francis M, Tejwani S, Dudeja G, Rajappa N, Sinha Roy A. Role of Age and Myopia in Simultaneous Assessment of Corneal and Extraocular Tissue Stiffness by Air-Puff Applanation. J Refract Surg. 2016 Jul 1;32(7):486-93. doi: 10.3928/1081597X-20160512-02.
PMID: 27400081
citation: Sinha Roy A, Kurian M, Matalia H, Shetty R. Air-puff associated quantification of non-linear biomechanical properties of the human cornea in vivo. J Mech Behav Biomed Mater. 2015 Aug;48:173-182. doi: 10.1016/j.jmbbm.2015.04.010. Epub 2015 Apr 20.
PMID: 25955559
responsible party type: Principal Investigator
investigator affiliation: Narayana Nethralaya
investigator full name: Dr Rohit Shetty
investigator title: Doctor
mesh term: Myopia
sharing ipd: No