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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03187821
Enrollment
1000
Registered
2017-06-15
Start date
2012-09-30
Completion date
2015-01-31
Last updated
2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Angle-Closure

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.

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.

Interventions

location of laser peripheral iridotomy

Sponsors

Johns Hopkins University
CollaboratorOTHER
Venkatesh Rengaraj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of new self-reported general eye or dysphotopsia symptoms6 MonthsQuestionnaire using a Likert scale

Secondary

MeasureTime frameDescription
Intraocular pressure6 Monthsmeasured in mmHg
Anterior chamber angle morphology6 Monthsmeasured in micrometers using anterior segment optical coherence tomography
Corneal endothelial cell count6 Monthsmeasured on a continuous scale
Choroidal thickness6 Monthsmeasured in micrometers using enhanced depth optical coherence tomography

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026