Glaucoma, Angle-ClosureNCT03187821
Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure
A study testing Laser peripheral iridotomy in people with Glaucoma, Angle-Closure, run by Venkatesh Rengaraj.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Laser peripheral iridotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of PACS or PAC/PACG in at least one eye
Who cannot join
- bilaterally pseudophakic
- prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye
- signs or symptoms consistent with acute angle closure at time of enrollment
About this study
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.
Read the 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.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Laser peripheral iridotomy
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser peripheral iridotomyProcedure or surgery
location of laser peripheral iridotomy
| Study group | Role | What they receive |
|---|---|---|
| Superior | Active comparator | Laser peripheral iridotomy done at superior part of iris. Receives: Procedure: Laser peripheral iridotomy |
| Nasal/temporal | Active comparator | Laser peripheral iridotomy done at temporal/nasal part of iris. Receives: Procedure: Laser peripheral iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of new self-reported general eye or dysphotopsia symptoms
Questionnaire using a Likert scale
Measured: 6 Months
Secondary outcomes (4)
Intraocular pressure
measured in mmHg
Measured: 6 Months
Anterior chamber angle morphology
measured in micrometers using anterior segment optical coherence tomography
Measured: 6 Months
Corneal endothelial cell count
measured on a continuous scale
Measured: 6 Months
Choroidal thickness
measured in micrometers using enhanced depth optical coherence tomography
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venkatesh Rengaraj
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor-investigator, Venkatesh Rengaraj, Aravind Eye Care System
- Investigators
- Rengaraj Venkatesh, DNB, Principal investigator, Aravind Eye Hospital, Pondicherry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187821
- Sponsor's protocol ID
- iface2pi
- Status last verified
- Jun 2017
- First submitted
- 14 Mar 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 24531024Jiang 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.
PubMed 22036632Kumar 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.
PubMed 23203700How 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.
PubMed 22410350Zebardast 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.
PubMed 32672653Srinivasan 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.
PubMed 29096997
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure
- ClinicalTrials.gov ID
- NCT03187821
- Acronym / sponsor ID
- iface2pi
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Venkatesh RengarajUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior | Active comparator | Procedure: Laser peripheral iridotomyLaser peripheral iridotomy done at superior part of iris. |
| Nasal/temporal | Active comparator | Procedure: Laser peripheral iridotomyLaser peripheral iridotomy done at temporal/nasal part of iris. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of PACS or PAC/PACG in at least one eye
Key exclusion criteria (3 listed)
- bilaterally pseudophakic
- prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye
- signs or symptoms consistent with acute angle closure at time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser peripheral iridotomylocation of laser peripheral iridotomy | Procedure or surgery | Nasal/temporal, Superior |
Primary outcome
Occurrence of new self-reported general eye or dysphotopsia symptoms
Time frame: 6 Months
Questionnaire using a Likert scale
4 secondary outcomes
Intraocular pressure
Time frame: 6 Months
Anterior chamber angle morphology
Time frame: 6 Months
Corneal endothelial cell count
Time frame: 6 Months
Choroidal thickness
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Background: PubMed 24531024Vera 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.
- Background: PubMed 22036632Jiang 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.
- Background: PubMed 23203700Kumar 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.
- Background: PubMed 22410350How 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.
- Derived from this study: PubMed 32672653Zebardast 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.
- Derived from this study: PubMed 29096997Srinivasan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rengaraj Venkatesh, DNB principal investigator
Aravind Eye Hospital, Pondicherry
Questions about this trial
What is this clinical trial studying?
A study testing Laser peripheral iridotomy in people with Glaucoma, Angle-Closure, run by Venkatesh Rengaraj.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of new self-reported general eye or dysphotopsia symptoms (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187821, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.