CTRI

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CTRI Number

CTRI/2017/12/010922 [Registered on: 20/12/2017] Trial Registered Retrospectively

Last Modified On:

20/11/2019

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

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

Scientific Title of Study

A Prospective, Randomized Study to Compare the Safety and Efficacy of Topical 0.1% Nepafenac Eye Drops with Topical 1% Prednisolone Acetate Eye Drops in Primary Angle Closure Suspects Undergoing YAG Peripheral Iridotomy.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Keerthi Gayam
Designation	DNB Resident
Affiliation	Aravind eye hospital
Address	Room no. 21, Deptartment of Glaucoma, Aravind eye hospital, Thavalakuppam, Cuddalore main road, Pondicherry Pondicherry PONDICHERRY 605007 India
Phone
Fax
Email	keerthigayam16@gmail.com

Details of Contact Person
Scientific Query

Name	Dr R Venkatesh
Designation	Cheif Medical Officer
Affiliation	Aravind eye hospital
Address	Room no.21, Department of Glaucoma, Aravind eye hospital, Thavalakuppam, Cuddalore main road, Pondicherry Pondicherry PONDICHERRY 605007 India
Phone
Fax
Email	venkatesh@pondy.aravind.org

Details of Contact Person
Public Query

Name	Dr Keerthi Gayam
Designation	DNB Resident
Affiliation	Aravind eye hospital
Address	Room no. 21, Department of Glaucoma, Aravind eye hospital, Thavalakuppam, Cuddalore main road, Pondicherry Pondicherry PONDICHERRY 605007 India
Phone
Fax
Email	keerthigayam16@gmail.com

Source of Monetary or Material Support

Room no. 21, Department of Glaucoma, Aravind eye hospital, Thavalakuppam, Cuddalore main road, Pondicherry.

Primary Sponsor

Name	Aravind eye hospital
Address	Thavalakuppam, Cuddalore main road, Pondicherry.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Keerthi Gayam	Aravind eye hospital	Room no. 8, Department of Glaucoma, Thavalakuppam, Cuddalore main road, Pondicherry Pondicherry PONDICHERRY	9626199245 keerthigayam16@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Aravind Medical Research Foundation, Madurai	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	(1) ICD-10 Condition: H408\|\|Other glaucoma, Primary angle closure suspects undergoing laser peripheral iridotomy,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nepafenac 0.1% topical eye drops, one drop 4 times/day for 7 days then 2 times/day for additional 7 days. Total duration 14 days.	Non steroidal anti-inflammatory drug
Intervention	Prednisolone acetate 1% topical eye drops, one drop 4 times/day for 7 days then 2 times/day for additional 7 days. Total duration 14 days.	Steroidal anti-inflammatory drug

Inclusion Criteria

Age From	40.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Best corrected visual acuity 6/9 or more 2. Primary angle closure suspects

ExclusionCriteria

Details

1. Corneal pathology
2. Significant cataract (obscuring undilated fundus view)
3. Intra ocular pressure more than 21 mm of Hg
4. Peripheral anterior synechiae
5. Glaucomatous optic neuropathy
6. 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

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
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

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

Target Sample Size

Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "152"
Final Enrollment numbers achieved (India)="152"

Phase of Trial

Phase 4

Date of First Enrollment (India)

11/08/2014

Date of Study Completion (India)

27/01/2016

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="9"
Days="7"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

This study is NOT YET published in any journal.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

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.