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

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).

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panretinal Photocoagulation

Procedure

In cases of proliferative diabetic retinopathy (PDR), panretinal photocoagulation (PRP) is the first-line treatment. Although PRP reduces the risk of severe vision loss, it has been shown that laser energy can cause destruction to all layers of retina including the ganglion cells and the retinal nerve fiber layer (RNFL), and therefore generate visual field defects similar to that observed in glaucomatous damage. In such cases, visual field testing can be less helpful to evaluate glaucomatous damage in PDR patients treated with PRP.

Primary outcomes

Cup area

Time frame: 12 months

Change in cup area (mm2) measured by Heidelberg retinal tomograph (HRT) before and one year after PRP

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Effect of Panretinal Photocoagulation on Confocal Laser Scanning Ophthalmoscopy and Stereo Photographic Parameters of the Optic Disc Topography in Diabetic Retinopathy Patients

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Mar 26, 2018
Registry last updated: Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed