<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/NCT03786146</url>
  </required_header>
  <id_info>
    <org_study_id>RNFL in diabetic after PRP</org_study_id>
    <nct_id>NCT03786146</nct_id>
  </id_info>
  <brief_title>Changes in Retinal Nerve Fiber Layer Thickness Detected by OCT in Diabetic Retinopathy After Panretinal Photocoagulation</brief_title>
  <official_title>Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic&#xD;
      retinopathy. It is recognized that laser expansion into the retina may be associated with&#xD;
      photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss.&#xD;
&#xD;
      Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore,&#xD;
      retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it&#xD;
      can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber&#xD;
      layer thickness in the latter follow up period.&#xD;
&#xD;
      Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which&#xD;
      is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre laser assessment:&#xD;
&#xD;
        -  Assessment of medical and family history&#xD;
&#xD;
        -  Refraction and best corrected visual acuity&#xD;
&#xD;
        -  Anterior segment examination using binocular slit lamp bi-microscopy.&#xD;
&#xD;
        -  Posterior segment examination.&#xD;
&#xD;
        -  OCT scan of peripapillary area&#xD;
&#xD;
      Post laser assessment ( at 1,3 and 6 months):&#xD;
&#xD;
        -  Refraction and best corrected visual acuity.&#xD;
&#xD;
        -  Anterior segment examination using binocular slit lamp bi-microscopy.&#xD;
&#xD;
        -  Posterior segment examination.&#xD;
&#xD;
        -  OCT scan of peripapillary area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.</measure>
    <time_frame>0 (before laser treatment ).</time_frame>
    <description>A 3.4 mm OCT circular scan will be positioned around the optic nerve head.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.</measure>
    <time_frame>1 month post laser treatment.</time_frame>
    <description>A 3.4 mm OCT circular scan will be positioned around the optic nerve head.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.</measure>
    <time_frame>3 months post laser treatment.</time_frame>
    <description>A 3.4 mm OCT circular scan will be positioned around the optic nerve head.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.</measure>
    <time_frame>6 months post laser treatment.</time_frame>
    <description>A 3.4 mm OCT circular scan will be positioned around the optic nerve head.</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Retinal Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be carried out on patients with a clinical diagnosis of proliferative&#xD;
        diabetic retinopathy treated by panretinal photocoagulation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a clinical diagnosis of proliferative diabetic retinopathy.&#xD;
&#xD;
          -  Treated by panretinal photocoagulation.&#xD;
&#xD;
          -  Age between 40-70 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with densely opaque media (as dense cataract or vitreous hemorrhage).&#xD;
&#xD;
          -  Glaucomatous patients.&#xD;
&#xD;
          -  Any other associated retinopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>rania goda</last_name>
    <role>Principal Investigator</role>
    <affiliation>researcher in Assiut university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ehab wasfi</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali Netag</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kamel Abd Elnaser</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ehab wasfi, assist prof</last_name>
    <phone>00201000373344</phone>
    <email>ehabinegypt@hotmail.com</email>
  </overall_contact>
  <reference>
    <citation>Wagdy F, El Sobky H, Sarhan AE-R, Hafez M. Evaluation of retinal nerve fiber layer thickness in diabetic retinopathy by optical coherence tomography after full scatter panretinal argon laser photocoagulation. J Egypt Ophthalmol Soc [Internet]. 2013 Jul 1;106(3):153-8. Available from: http://www.jeos.eg.net/article.asp?issn=2090-0686</citation>
  </reference>
  <reference>
    <citation>Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.</citation>
    <PMID>19337475</PMID>
  </reference>
  <reference>
    <citation>Kim J, Woo SJ, Ahn J, Park KH, Chung H, Park KH. Long-term temporal changes of peripapillary retinal nerve fiber layer thickness before and after panretinal photocoagulation in severe diabetic retinopathy. Retina. 2012 Nov-Dec;32(10):2052-60. doi: 10.1097/IAE.0b013e3182562000.</citation>
    <PMID>23099450</PMID>
  </reference>
  <reference>
    <citation>Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.</citation>
    <PMID>15161831</PMID>
  </reference>
  <reference>
    <citation>Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.</citation>
    <PMID>19597104</PMID>
  </reference>
  <reference>
    <citation>Muqit MM, Wakely L, Stanga PE, Henson DB, Ghanchi FD. Effects of conventional argon panretinal laser photocoagulation on retinal nerve fibre layer and driving visual fields in diabetic retinopathy. Eye (Lond). 2010 Jul;24(7):1136-42. doi: 10.1038/eye.2009.308. Epub 2009 Dec 18.</citation>
    <PMID>20019760</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Rania M. Goda</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03786146
org study id: RNFL in diabetic after PRP
nct id: NCT03786146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic
      retinopathy. It is recognized that laser expansion into the retina may be associated with
      photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss.

      Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore,
      retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it
      can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber
      layer thickness in the latter follow up period.

      Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which
      is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.
Pre laser assessment:

        -  Assessment of medical and family history

        -  Refraction and best corrected visual acuity

        -  Anterior segment examination using binocular slit lamp bi-microscopy.

        -  Posterior segment examination.

        -  OCT scan of peripapillary area

      Post laser assessment ( at 1,3 and 6 months):

        -  Refraction and best corrected visual acuity.

        -  Anterior segment examination using binocular slit lamp bi-microscopy.

        -  Posterior segment examination.

        -  OCT scan of peripapillary area.
observational model: Case-Crossover
time perspective: Prospective
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
time frame: 0 (before laser treatment ).
description: A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
time frame: 1 month post laser treatment.
description: A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
time frame: 3 months post laser treatment.
description: A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
time frame: 6 months post laser treatment.
description: A 3.4 mm OCT circular scan will be positioned around the optic nerve head.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
last name: rania goda
role: Principal Investigator
affiliation: researcher in Assiut university
last name: ehab wasfi
role: Study Director
affiliation: Assiut University
last name: Ali Netag
role: Study Director
affiliation: Assiut University
last name: Kamel Abd Elnaser
role: Study Chair
affiliation: Assiut University
last name: ehab wasfi, assist prof
phone: 00201000373344
email: ehabinegypt@hotmail.com
citation: Wagdy F, El Sobky H, Sarhan AE-R, Hafez M. Evaluation of retinal nerve fiber layer thickness in diabetic retinopathy by optical coherence tomography after full scatter panretinal argon laser photocoagulation. J Egypt Ophthalmol Soc [Internet]. 2013 Jul 1;106(3):153-8. Available from: http://www.jeos.eg.net/article.asp?issn=2090-0686
citation: Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.
PMID: 19337475
citation: Kim J, Woo SJ, Ahn J, Park KH, Chung H, Park KH. Long-term temporal changes of peripapillary retinal nerve fiber layer thickness before and after panretinal photocoagulation in severe diabetic retinopathy. Retina. 2012 Nov-Dec;32(10):2052-60. doi: 10.1097/IAE.0b013e3182562000.
PMID: 23099450
citation: Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.
PMID: 15161831
citation: Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.
PMID: 19597104
citation: Muqit MM, Wakely L, Stanga PE, Henson DB, Ghanchi FD. Effects of conventional argon panretinal laser photocoagulation on retinal nerve fibre layer and driving visual fields in diabetic retinopathy. Eye (Lond). 2010 Jul;24(7):1136-42. doi: 10.1038/eye.2009.308. Epub 2009 Dec 18.
PMID: 20019760
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Rania M. Goda
investigator title: principle investigator
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
sharing ipd: Undecided