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

NCT ID: NCT03476967

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pretreatment x Posttreatment

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.

Panretinal photocoagulation

Intervention Type: 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.

Interventions

Panretinal photocoagulation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leandro Zacharias

Role: STUDY_DIRECTOR

Division of Ophthalmology, University of São Paulo Medical School, São Paulo, Brazil

Other Identifiers

USaoPauloGH 12423

Identifier Type: -

Identifier Source: org_study_id