Comparison Between Grid Macular Laser and Topical Bromfenac 0.09% in the Treatment of Diabetic Macular Edema
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
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%
Twice daily eye drop bromfenac 0.09% for 6 weeks
Intervention: eye drop bromfenac 0.09% (Drug)
Observation
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