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

Glaucoma, Angle-Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187821
• Other study ID #: iface2pi
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: June 14, 2017
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2017
• Source: Aravind Eye Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Angle-Closure

Intervention

Procedure:
• Laser peripheral iridotomy
location of laser peripheral iridotomy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Venkatesh Rengaraj	Johns Hopkins University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of new self-reported general eye or dysphotopsia symptoms	Questionnaire using a Likert scale	6 Months
Secondary	Intraocular pressure	measured in mmHg	6 Months
Secondary	Anterior chamber angle morphology	measured in micrometers using anterior segment optical coherence tomography	6 Months
Secondary	Corneal endothelial cell count	measured on a continuous scale	6 Months
Secondary	Choroidal thickness	measured in micrometers using enhanced depth optical coherence tomography	6 Months