MedTrace Logo

Comparison of Treatments in Diabetic Macular Edema

NCT05715385 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-13

No results posted yet for this study

Summary

Prospective or cohort study to compare the effects of grid macular laser, topical bromfenac 0.09% and placebo (carboxymethyl cellulose 0.5%) medication in diabetic macular edema.

60 eyes with macular edema of two types i.e. cystoid macular edema (CME) and clinically significant macular edema (CSME) were divided into three groups with 20 patients in each group. One group was treated with grid laser photocoagulation, the second group was treated with topical bromfenac 0.09% drops two times a day and the third group was treated with topical carboxy methyl cellulose 0.5% three times a day (placebo treatment).

Conditions

Interventions

PROCEDURE

laser photocoagulation

Laser Parameters of grid photocoagulation Diffuse diabetic macular edema is treated by a grid pattern of laser. The grid is applied to areas of retinal thickening with diffuse leakage or capillary non-perfusion. Spot size: 50-100 micron is utilized. The burn intensity for grid laser: barely visible (light grey). Power of laser burn is between 80-100 mw depending on the condition of the laser, the opacities in the media and background pigmentation. Laser burns should be placed at least one burn width apart, wider if thickening is less severe. If necessary, the grid can extend up to 2 disc diameters superiorly, inferiorly, and temporally from the centre of the macula. One should avoid treating within 500 microns of the disc margin or the centre of the macula. Duration of about 0.05-0.1 sec is used Number of spots- 100-500

DRUG

eye drop bromfenac 0.09%

twice daily e/d bromfenac 0.09% for 6 weeks

DRUG

Placebo

Observation group. No intervention done. Only eye drop carboxymethyl cellulose 0.5% to be instilled thrice a day for 6 weeks.

Sponsors & Collaborators

  • Babasaheb Ambedkar Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Mehul Joshi, FRCS,DNB · Dr Babasaheb Ambedkar Central Railway Hospital, Byculla, Mumbai, Maharashtra, India

  • Arundhati Malviya, MS(Ophthal) · Dr Babasaheb Ambedkar Central Railway Hospital, Byculla, Mumbai, Maharashtra, India

  • Memuna Bahadur, MS(Ophthal) · Dr Babasaheb Ambedkar Central Railway Hospital, Byculla, Mumbai, Maharashtra, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-10-31
Completion
2015-10-31

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05715385 on ClinicalTrials.gov