Skip to main content
Clinical Trials/NCT05715385
NCT05715385CompletedPhase 4

Comparison Between Grid Macular Laser and Topical Bromfenac 0.09% in the Treatment of Diabetic Macular Edema

Babasaheb Ambedkar Memorial Hospital0 sites60 target enrollmentStarted: November 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
60
Primary Endpoint
Change in visual acuity in laser photocoagulation group

Study Overview

Brief 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).

Detailed Description

Study site:

Dr Babasaheb Ambedkar Memorial Hospital, of the Central Railway at Byculla, Mumbai.

Study Population:

Patients attending Ophthalmology Out Patient Department(OPD) at Dr Babasaheb Ambedkar Memorial Central Railway Hospital, Byculla, Mumbai.

Study design:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient with type 1 or type 2 diabetes.
  • The study eye met the following:
  • OCT thickness of the macula upto 400 microns.
  • On clinical examination, definite retinal thickening due to diabetic macular edema within 3000 μm of the center of the macula.
  • Patient with well controlled blood sugar levels i.e. fasting blood sugar level < 110mg% and post prandial blood sugar level < 126 mg%. Also HbA1c level less than 7%.
  • Able and willing to provide informed consent.
  • Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT and fundus photographs.
  • Normal optic disc.

Exclusion Criteria

  • Use of systemic corticosteroids for any other systemic condition or previous anti-Vascular endothelial growth factor (VEGF) therapy.
  • Current use of prescription systemic NSAIDs.
  • Known allergy to bromfenac.
  • History of use of NSAID eye drops within the last 30 days or anticipated need for such drops during the study due to other ocular conditions.
  • Any ocular condition, coexisting with diabetic macular edema, which might affect visual acuity.

Arms & Interventions

Laser photocoagulation

Active Comparator

Grid laser was performed under topical anesthesia with frequency doubled Nd YAG laser of wavelength 532 nm.

Laser Parameters for grid photocoagulation Lens used: Mainster grid lens Spot size: 75-100μ The burn intensity for grid laser: barely visible (light grey) Power: 80-100mw depending on the condition of the laser, the opacities in the media and background pigmentation.

Duration: 100msec No. of spots: 80-100 Laser burns were placed at least one burn width apart. Wider if the thickening was less severe. If necessary, the grid laser extended up to 2 disc diameters superiorly, inferiorly and temporally from the centre of the macula. Treating the area within 500 microns of the disc margin or the centre of the macula was avoided.

Intervention: laser photocoagulation (Procedure)

Bromfenac 0.09%

Active Comparator

Twice daily eye drop bromfenac 0.09% for 6 weeks

Intervention: eye drop bromfenac 0.09% (Drug)

Observation

Placebo Comparator

Eye drop carboxymethyl cellulose 0.5% to be instilled thrice a day for 6 weeks

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Change in visual acuity in laser photocoagulation group

Time Frame: Baseline and 6 weeks

Best corrected visual acuity will be measured by logMAR scale

Change in visual acuity in bromfenac group

Time Frame: Baseline and 6 weeks

Best corrected visual acuity will be measured by logMAR scale

Change in visual acuity in observation group

Time Frame: Baseline and 6 weeks

Best corrected visual acuity will be measured by logMAR scale

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Babasaheb Ambedkar Memorial Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Similar Trials

Comparison of Treatments in Diabetic... | Clinical Trial