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

December 21, 2018 updated by: Rania M. Goda, Assiut University

Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 (before laser treatment ).
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.
1 month post laser treatment.
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.
3 months post laser treatment.
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.
6 months post laser treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 21, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNFL in diabetic after PRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe