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Changes in Retinal Nerve Fiber Layer Thickness Detected by OCT in Diabetic Retinopathy After Panretinal Photocoagulation

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ClinicalTrials.gov Identifier: NCT03786146
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rania M. Goda, Assiut University

Brief Summary:

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.


Condition or disease
Retinal Disease

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers. [ Time Frame: 0 (before laser treatment ). ]
    A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  2. Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers. [ Time Frame: 1 month post laser treatment. ]
    A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  3. Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers. [ Time Frame: 3 months post laser treatment. ]
    A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  4. Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers. [ Time Frame: 6 months post laser treatment. ]
    A 3.4 mm OCT circular scan will be positioned around the optic nerve head.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study will be carried out on patients with a clinical diagnosis of proliferative diabetic retinopathy treated by panretinal photocoagulation.
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of proliferative diabetic retinopathy.
  • Treated by panretinal photocoagulation.
  • Age between 40-70 years old.

Exclusion Criteria:

  • Patients with densely opaque media (as dense cataract or vitreous hemorrhage).
  • Glaucomatous patients.
  • Any other associated retinopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786146


Contacts
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Contact: ehab wasfi, assist prof 00201000373344 ehabinegypt@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: rania goda researcher in Assiut university
Study Director: ehab wasfi Assiut University
Study Director: Ali Netag Assiut University
Study Chair: Kamel Abd Elnaser Assiut University

Publications:
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

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Responsible Party: Rania M. Goda, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03786146     History of Changes
Other Study ID Numbers: RNFL in diabetic after PRP
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases