Glaucoma, Angle-ClosureNCT03352492
Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
A study testing Superior laser peripheral iridotomy and Temporal laser peripheral iridotomy in people with Glaucoma, Angle-Closure, run by University of the Incarnate Word at 1 site in United States.
Trial summary
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Superior laser peripheral iridotomy and Temporal laser peripheral iridotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angle-closure glaucoma
- Angle-closure glaucoma suspect
Who cannot join
- Monocular status
- Previous intraocular surgery
- Visual acuity worse than 20/40
- Prior episode of acute angle-closure glaucoma
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of the Incarnate Word
San Antonio, Texas, 78209
Ana C Hagendorf, PhD, 210-805-3036, wandless@uiwtx.edu
About this study
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Superior laser peripheral iridotomy, Temporal 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.
Superior laser peripheral iridotomyProcedure or surgery
Iridotomy placement between 11:00 and 1:00 o'clock
Temporal laser peripheral iridotomyProcedure or surgery
Iridotomy placement at 3:00 or 9:00 o'clock
| Study group | Role | What they receive |
|---|---|---|
| Bilateral iridotomy: Superior | Experimental | Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye. Receives: Procedure: Superior laser peripheral iridotomy |
| Bilateral iridotomy: Temporal | Experimental | Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye. Receives: Procedure: Temporal laser peripheral iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart
Measured: 30 days post-operative
Secondary outcomes (2)
Change in Peli-Robson contrast sensitivity
Change from baseline in contrast sensitivity evaluated in number of letters correctly read on the Peli-Robson chart
Measured: 30 days post-operative
Change in CSV-1000 contrast sensitivity
Change from baseline in contrast sensitivity evaluated using the number of correct responses on the CSV-1000 test
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jan 2018
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paired eye
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Trevino, OD, FAAO, University of the Incarnate Word
- Investigators
- Richard Trevino, OD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352492
- Sponsor's protocol ID
- 16-02-003
- Status last verified
- Apr 2020
- First submitted
- 20 Nov 2017
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
- ClinicalTrials.gov ID
- NCT03352492
- Acronym / sponsor ID
- 16-02-003
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 24 Nov 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.
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Paired eye
| Arm | Type | Receives |
|---|---|---|
| Bilateral iridotomy: Superior | Experimental | Procedure: Superior laser peripheral iridotomyEach subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye. |
| Bilateral iridotomy: Temporal | Experimental | Procedure: Temporal laser peripheral iridotomyEach subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Angle-closure glaucoma
- Angle-closure glaucoma suspect
Key exclusion criteria (5 listed)
- Monocular status
- Previous intraocular surgery
- Visual acuity worse than 20/40
- Prior episode of acute angle-closure glaucoma
- Pregnancy
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 |
|---|---|---|
| Superior laser peripheral iridotomyIridotomy placement between 11:00 and 1:00 o'clock | Procedure or surgery | Bilateral iridotomy: Superior |
| Temporal laser peripheral iridotomyIridotomy placement at 3:00 or 9:00 o'clock | Procedure or surgery | Bilateral iridotomy: Temporal |
Primary outcome
Change in visual acuity
Time frame: 30 days post-operative
Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart
2 secondary outcomes
Change in Peli-Robson contrast sensitivity
Time frame: 30 days post-operative
Change in CSV-1000 contrast sensitivity
Time frame: 30 days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Richard Trevino, OD principal investigator
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superior laser peripheral iridotomy and Temporal laser peripheral iridotomy in people with Glaucoma, Angle-Closure, run by University of the Incarnate Word at 1 site in United States.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Hagendorf, PhD (210-805-3036, wandless@uiwtx.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity (time frame: 30 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2020.