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

NCT03476967 | Completed

• 1 other identifier: USaoPauloGH 12423
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetic Retinopathy

Keywords

optic disc topography; panretinal photocoagulation; confocal scanning laser ophthalmoscopy; stereoscopic disc photographs; diabetic retinopathy; optic nerve head parameters

Outcome Measures

Primary Outcomes (1)

• Cup area

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

  12 months

Study Arms (1)

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.

Procedure: Panretinal photocoagulation

Interventions

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.

Pretreatment x Posttreatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients followed in the ophthalmology department of Hospital das Clínicas da FMUSP who have type I or II diabetes mellitus and present severe or very severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy in cases where retinal panphotocoagulation is indicated.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Leandro Zacharias

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 26, 2018
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 26, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months after study publication
• Access Criteria: Data access request will be reviewed by study director. Requestors will be required to sign a Data access agreement