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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476967
• Other study ID #: USaoPauloGH 12423
• Status: Completed
• First received: March 9, 2018
• Last updated: March 22, 2018
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: March 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cup area	Change in cup area (mm2) measured by Heidelberg retinal tomograph (HRT) before and one year after PRP	12 months