Effect of Laser Treatment for Diabetic Retinopathy on the Optic Disc Topography

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Procedure: Panretinal photocoagulation

• Registration Number: NCT03476967
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal photocoagulation to determine the effect on optic disc topographic parameters in non-glaucomatous patients with proliferative diabetic retinopathy (PDR).

Detailed Description

Glaucoma and proliferative diabetic retinopathy (PDR) are two very prevalent diseases that often coexist. Previous literature suggest that panretinal photocoagulation may somehow lead to optic disk cupping. Therefore, evaluation of the optic disc cupping and of possible glaucomatous damage in patients with diabetic retinopathy can be difficult, especially after PRP treatment. The purpose of this study is to determine the long-term effect of PRP on optic disc topographic parameters in non-glaucomatous patients with PDR using Heidelberg retina tomograph (HRT) parameters and stereo photography. The Investigators found that PRP does not cause morphological optic disk changes in diabetic PDR patients after one year of follow-up.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Study First Posted: 2018-03-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diagnosis of PDR (due to type 1 or 2 diabetes mellitus)
• intraocular pressure < 18 mmHg
• nonglaucomatous optic disc characteristics at fundus examination
• vertical cup-to-disc (C/D) ratio <0.7
• absence of media opacities

Exclusion Criteria

• previous diagnosis of glaucoma
• family history of glaucoma
• neuroophthalmic disease
• uveitis
• retinal artery or vein occlusion
• optic disc neovascularization
• diabetic macular edema (DME)
• corneal opacity
• previous laser photocoagulation treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pretreatment x Posttreatment	Panretinal photocoagulation	The group was evaluated through non-invasive complementary examinations before laser therapy and at the 1-year follow-up visit to analyze possible optical disc alterations that may occur after retinal panretinal photocoagulation in patients with proliferative diabetic retinopathy.

Primary Outcome Measures

Name	Time	Method
Cup area	12 months	Change in cup area (mm2) measured by Heidelberg retinal tomograph (HRT) before and one year after PRP