NCT03187821

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

March 14, 2017

Last Update Submit

June 14, 2017

Conditions

Glaucoma, Angle-Closure

Outcome Measures

Primary Outcomes (1)

  • Occurrence of new self-reported general eye or dysphotopsia symptoms

    Questionnaire using a Likert scale

    6 Months

Secondary Outcomes (4)

  • Intraocular pressure

    6 Months

  • Anterior chamber angle morphology

    6 Months

  • Corneal endothelial cell count

    6 Months

  • Choroidal thickness

    6 Months

Study Arms (2)

Superior

ACTIVE COMPARATOR

Laser peripheral iridotomy done at superior part of iris.

Procedure: Laser peripheral iridotomy

Nasal/temporal

ACTIVE COMPARATOR

Laser peripheral iridotomy done at temporal/nasal part of iris.

Procedure: Laser peripheral iridotomy

Interventions

Laser peripheral iridotomyPROCEDURE

location of laser peripheral iridotomy

Nasal/temporalSuperior

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • bilaterally pseudophakic
  • prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye
  • signs or symptoms consistent with acute angle closure at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 24531024BACKGROUND

  • 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.

    PMID: 22036632BACKGROUND

  • 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.

    PMID: 23203700BACKGROUND

  • 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.

    PMID: 22410350BACKGROUND

  • Zebardast N, Kavitha S, Palaniswamy K, Kader MA, Raman G, Rajendrababu S, Ramulu PY, Rengaraj V. Predictors of Short-Term Intraocular Pressure Change after Laser Peripheral Iridotomy: A Prospective Randomized Study. Ophthalmol Glaucoma. 2018 Nov-Dec;1(3):197-205. doi: 10.1016/j.ogla.2018.10.005. Epub 2018 Oct 19.

    PMID: 32672653DERIVED

  • Srinivasan K, Zebardast N, Krishnamurthy P, Abdul Kader M, Raman GV, Rajendrababu S, Venkatesh R, Ramulu PY. Comparison of New Visual Disturbances after Superior versus Nasal/Temporal Laser Peripheral Iridotomy: A Prospective Randomized Trial. Ophthalmology. 2018 Mar;125(3):345-351. doi: 10.1016/j.ophtha.2017.09.015. Epub 2017 Oct 31.

    PMID: 29096997DERIVED

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Rengaraj Venkatesh, DNB

    Aravind Eye Hospital, Pondicherry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

March 14, 2017

First Posted

June 15, 2017

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

June 15, 2017

Record last verified: 2017-06