A clinical study to see the effects of two different drugs, in patients undergoing laser for angle closure glaucoma

Phase 4

Completed

• Conditions: Other glaucoma, Primary angle closure suspects undergoing laser peripheral iridotomy,

• Registration Number: CTRI/2017/12/010922
• Lead Sponsor: Aravind eye hospital

Brief Summary

This study is a randomized, double blind, parallel group trial comparing the safety and efficacy of topical 0.1% Nepafenac eye drops with topical 1% Prednisolone acetate eye drops in primary angle closure suspects undergoing Nd:YAG peripheral iridotomy conducted at one centre in India. The primary outcome measure was level of anterior chamber inflammation control at 2 and 4 weeks between the two groups. The secondary outcome measure was change in IOP at 2 and 4 weeks between the two groups.

Results:

1. Both the groups were comparable in age and gender distribution. The higher number of females in study population is consistent with the finding that females are at higher risk for primary angle closure disease.

2. There was no significant difference in inflammation control between the two groups

3. The difference in mean IOP from baseline was significantly higher in Prednisolone group (p-value <0.001) at 2 weeks follow up where as it was insignificantly higher in Prednisolone group at 4weeks follow up.

4. Recurrent iritis was seen in 4 (5.8%) patients in Prednisolone group within 2 days after stopping steroid eye drops.

5. At 2 weeks, Nd:YAG iridotomy was repeated in 8 patients in Prednisolone group, but none in Nepafenac group needed repeat YAG iridotomy.



Conclusion: Topical Nepafenac 0.1% eye drop is as effective as topical Prednisolone acetate 1% eye drop in controlling inflammation after Nd:YAG peripheral iridotomy, with lesser side effects like intraocular pressure elevation, recurrent iritis and closure of iridotomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-08
• Study Completion: 2016-01-27
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Best corrected visual acuity 6/9 or more 2.
• Primary angle closure suspects.

Exclusion Criteria

• Corneal pathology 2.
• Significant cataract (obscuring undilated fundus view) 3.
• Intra ocular pressure more than 21 mm of Hg 4.
• Peripheral anterior synechiae 5.
• History of use of topical or systemic steroids one month prior to laser iridotomy 7.
• History of use of topical or systemic NSAIDS one month prior to laser iridotomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare level of anterior chamber inflammation control between 0.1% Nepafenac and 1% Prednisolone acetate groups.	2 weeks and 4 weeks post laser

Secondary Outcome Measures

Name	Time	Method
To compare the changes in IOP between 0.1% Nepafenac and 1% Prednisolone acetate groups.	2 weeks and 4 weeks post laser

Trial Locations

Locations (1)

Aravind eye hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Aravind eye hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr Keerthi Gayam

Principal investigator

9626199245

keerthigayam16@gmail.com