Comparison of visual outcome between two different Intraocular injections for swelling of nerve tissue of eye in patients with Intraocular lens

Phase 4

Not yet recruiting

• Conditions: Background retinopathy and retinalvascular changes,

• Registration Number: CTRI/2022/03/040844

Brief Summary

Diabetic retinopathy is a disease of the nervous tissue in the eye resulting uncontrolled diabetes mellitus. A common complication of this is diabetic macular edema, which is accumulation of fluid in this nervous tissue and causes significant vision loss.

In this study, we compare two commonly used drugs - Bevacizumab (Anti VEGF) and Triamcinolone acetonide (steroid) given inside the eye (intravitreally) to resolve this edema to see which is more effective



Most studies comparing these two drugs, compare the outcome using two parameters. First is visual acuity representing functional outcome and second is thickness of this nervous tissue representing anatomical outcome



In our study, we are using retinal sensitivity, which represent how sensitive the nervous tissue is to the light, as the functional outcome. The macular retinal sensitivity is measured using microperimetry and has shown to be a better parameter to evaluate functional outcomes when compared to visual acuity.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-03
• Study Start: 2022-03-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Central subfield retinal thickness of at least 300um measured by OCT 2.
• Centre involving macular edema 3.
• Visual acuity between 6/9 to 6/60.

Exclusion Criteria

• 1. Previous treatment in terms of :.
• a) Focal/macular photocoagulation b) Previous intravitreal injection therapy.
• Last 3 months c) PRP in the last 6 months 2. Any medial opacity obscuring the fundus view 3. Intra ocular pressure >21mmHg or previous steroid responders 4. Cataract surgery and YAG capsulotomy in the last 3 months 5. PDRP patients requiring simultaneous pan-retinal photocoagulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement and comparison of average threshold for macular sensitivity via microperimetry between the two treatment arms	0, 1, 6 month

Secondary Outcome Measures

Name	Time	Method
Measurement and comparison of VA (snellen’s 3 metre), CSRT (OCT), fixation characteristics (microperimetry) and number of injections given between the two treatment arms

Trial Locations

Locations (1)

Aravind Eye Hospital, Madurai; 🇮🇳 Madurai, TAMIL NADU, India

Aravind Eye Hospital, Madurai

🇮🇳Madurai, TAMIL NADU, India

Dr Sameer

Principal investigator

9958702003

sameerchaudhary22@outlook.com