Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure

• Sponsor: Venkatesh Rengaraj (Other)
• Overall Status: Completed
• CT.gov ID: NCT03187821
• Collaborator: Johns Hopkins University (Other)
• Enrollment: 1,000
• Arms: 2
• Duration (Months): 28

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if location of laser peripheral iridotomy (LPI) that is the standard of care treatment for angle closure glaucoma is related to changes in post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle morphology and onset of new visual disturbances.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Angle-Closure	Procedure: Laser peripheral iridotomy	N/A

Detailed Description

Study hypothesis: Location of laser peripheral iridotomy affects occurrence of post-operative dysphotopsia symptoms, intraocular pressure, anterior chamber angle morphology and corneal endothelial cell count Study design: Multicenter randomized, prospective, single masked trial Trial setting: Hospitals Trial type: Treatment

Interventions: South Indian subjects aged 30 years or greater, with primary angle closure suspect (PACS) or primary angle closure/ primary angle closure glaucoma(PAC/PACG) will be randomized to either bilateral superior or nasal/temporal laser peripheral iridotomy. Subjects will undergo noninvasive testing and imaging studies to measure IOP, anterior chamber angle morphology and endothelial cell count and asked to answer a questionnaire at baseline and again at 2 weeks and 6 months after treatment Primary outcome measures: Occurrence of new self-reported general eye or dysphotopsia symptoms.

Secondary outcome measures: intraocular pressure, anterior chamber and anterior chamber angle morphology, endothelial cell count.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Superior Laser peripheral iridotomy done at superior part of iris.	Procedure: Laser peripheral iridotomy; location of laser peripheral iridotomy
Active Comparator: Nasal/temporal Laser peripheral iridotomy done at temporal/nasal part of iris.	Procedure: Laser peripheral iridotomy; location of laser peripheral iridotomy

Outcome Measures

Primary Outcome Measures

1. Occurrence of new self-reported general eye or dysphotopsia symptoms [6 Months]

   Questionnaire using a Likert scale

Secondary Outcome Measures

1. Intraocular pressure [6 Months]

   measured in mmHg

2. Anterior chamber angle morphology [6 Months]

   measured in micrometers using anterior segment optical coherence tomography

3. Corneal endothelial cell count [6 Months]

   measured on a continuous scale

4. Choroidal thickness [6 Months]

   measured in micrometers using enhanced depth optical coherence tomography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of PACS or PAC/PACG in at least one eye

Exclusion Criteria:

• bilaterally pseudophakic

• prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye

• signs or symptoms consistent with acute angle closure at time of enrollment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Venkatesh Rengaraj
• Johns Hopkins University

Investigators

• Principal Investigator: Rengaraj Venkatesh, DNB, Aravind Eye Hospital, Pondicherry

Study Documents (Full-Text)

None provided.

More Information

Publications

• How AC, Baskaran M, Kumar RS, He M, Foster PJ, Lavanya R, Wong HT, Chew PT, Friedman DS, Aung T. Changes in anterior segment morphology after laser peripheral iridotomy: an anterior segment optical coherence tomography study. Ophthalmology. 2012 Jul;119(7):1383-7. doi: 10.1016/j.ophtha.2012.01.019. Epub 2012 Mar 10.
• Jiang Y, Chang DS, Foster PJ, He M, Huang S, Aung T, Friedman DS. Immediate changes in intraocular pressure after laser peripheral iridotomy in primary angle-closure suspects. Ophthalmology. 2012 Feb;119(2):283-8. doi: 10.1016/j.ophtha.2011.08.014. Epub 2011 Oct 29.
• Kumar RS, Baskaran M, Friedman DS, Xu Y, Wong HT, Lavanya R, Chew PT, Foster PJ, Aung T. Effect of prophylactic laser iridotomy on corneal endothelial cell density over 3 years in primary angle closure suspects. Br J Ophthalmol. 2013 Mar;97(3):258-61. doi: 10.1136/bjophthalmol-2012-302013. Epub 2012 Nov 30.
• Vera V, Naqi A, Belovay GW, Varma DK, Ahmed II. Dysphotopsia after temporal versus superior laser peripheral iridotomy: a prospective randomized paired eye trial. Am J Ophthalmol. 2014 May;157(5):929-35. doi: 10.1016/j.ajo.2014.02.010. Epub 2014 Feb 14.

• Responsible Party: Venkatesh Rengaraj, Clinical Research Coordinator, Aravind Eye Care System
• ClinicalTrials.gov Identifier: NCT03187821
• Other Study ID Numbers: iface2pi
• First Posted: Jun 15, 2017
• Last Update Posted: Jun 15, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Glaucoma, Angle-Closure

Study Results

No Results Posted as of Jun 15, 2017