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

Primary Purpose

Glaucoma, Angle-Closure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser peripheral iridotomy
Sponsored by
Venkatesh Rengaraj
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Angle-Closure

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Superior

    Nasal/temporal

    Arm Description

    Laser peripheral iridotomy done at superior part of iris.

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

    Outcomes

    Primary Outcome Measures

    Occurrence of new self-reported general eye or dysphotopsia symptoms
    Questionnaire using a Likert scale

    Secondary Outcome Measures

    Intraocular pressure
    measured in mmHg
    Anterior chamber angle morphology
    measured in micrometers using anterior segment optical coherence tomography
    Corneal endothelial cell count
    measured on a continuous scale
    Choroidal thickness
    measured in micrometers using enhanced depth optical coherence tomography

    Full Information

    First Posted
    March 14, 2017
    Last Updated
    June 14, 2017
    Sponsor
    Venkatesh Rengaraj
    Collaborators
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03187821
    Brief Title
    Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure
    Official Title
    Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Venkatesh Rengaraj
    Collaborators
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Angle-Closure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Superior
    Arm Type
    Active Comparator
    Arm Description
    Laser peripheral iridotomy done at superior part of iris.
    Arm Title
    Nasal/temporal
    Arm Type
    Active Comparator
    Arm Description
    Laser peripheral iridotomy done at temporal/nasal part of iris.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laser peripheral iridotomy
    Intervention Description
    location of laser peripheral iridotomy
    Primary Outcome Measure Information:
    Title
    Occurrence of new self-reported general eye or dysphotopsia symptoms
    Description
    Questionnaire using a Likert scale
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Intraocular pressure
    Description
    measured in mmHg
    Time Frame
    6 Months
    Title
    Anterior chamber angle morphology
    Description
    measured in micrometers using anterior segment optical coherence tomography
    Time Frame
    6 Months
    Title
    Corneal endothelial cell count
    Description
    measured on a continuous scale
    Time Frame
    6 Months
    Title
    Choroidal thickness
    Description
    measured in micrometers using enhanced depth optical coherence tomography
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rengaraj Venkatesh, DNB
    Organizational Affiliation
    Aravind Eye Hospital, Pondicherry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    24531024
    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.
    Results Reference
    background
    PubMed Identifier
    22036632
    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.
    Results Reference
    background
    PubMed Identifier
    23203700
    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.
    Results Reference
    background
    PubMed Identifier
    22410350
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32672653
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    29096997
    Citation
    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.
    Results Reference
    derived

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

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