Open Angle GlaucomaNCT02628223

180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

A study testing Selective Laser Trabeculoplasty and Neodymium:Yttrium Aluminum Garnet (YAG) laser in people with Open Angle Glaucoma and Ocular Hypertension, run by Temple University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Open Angle Glaucoma, Ocular Hypertension, Glaucoma, Open Angle, Pseudo-exfoliative
What is being tested?: Selective Laser Trabeculoplasty and Neodymium:Yttrium Aluminum Garnet (YAG) laser
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 2 sitesUnited States
Study dates: Sep 2014to Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
greater than 18 years of age
initial intraocular pressure (IOP) of ≥ 21 mmHg

Who cannot join

prior medical or laser therapy to lower IOP
previous incisional glaucoma surgery before the study period

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Levin Luminais Chronister Eye Associates
Thorndale, Pennsylvania, 19372
Brandywine Eye Center
Wilmington, Delaware, 19810

Other trials in United States

About this study

Official title: A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

Read the detailed description

This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

Conditions: Open Angle Glaucoma, Ocular Hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, Pigment Dispersion Syndrome, Glaucoma
Being tested: Selective Laser Trabeculoplasty, Neodymium:Yttrium Aluminum Garnet (YAG) laser
Keywords: glaucoma, Elevated IOP, Selective Laser Trabeculoplasty, SLT, open angle glaucoma, ocular hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, pigment dispersion syndrome, Pseudoexfoliation, IOP ≥ 21 mmHg
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma, Glaucoma-Related Pigment Dispersion Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Selective Laser TrabeculoplastyProcedure or surgery
Also called SLT
The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
Neodymium:Yttrium Aluminum Garnet (YAG) laserDevice
Also called Nd:YAG laser
The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Study groups in NCT02628223
Study group	Role	What they receive
180 degrees	Active comparator	180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser Receives: Procedure: Selective Laser Trabeculoplasty; Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser
360 degrees	Active comparator	360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser Receives: Procedure: Selective Laser Trabeculoplasty; Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up
Measured: 3 months

Secondary outcomes (3)

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up
Measured: 1 year
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required
Measured: within 1 year of study intervention
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up
Measured: within 1 year of study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2017

First posted11 Dec 2015 (estimated)
Study startSep 2014
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open Angle GlaucomaStudies 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: Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02628223
Sponsor's protocol ID: 21921
Status last verified: Nov 2020
First submitted: 23 Nov 2015
Last updated: 5 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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All Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
ClinicalTrials.gov ID: NCT02628223
Acronym / sponsor ID: 21921
Conditions: Open Angle Glaucoma, Ocular Hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, Pigment Dispersion Syndrome, Glaucoma
Keywords: glaucoma, Elevated IOP, Selective Laser Trabeculoplasty, SLT, open angle glaucoma, ocular hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, pigment dispersion syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Study start: Sep 2014
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 11 Dec 2015 (estimated)
Results: Posted 5 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
180 degrees	Active comparator	Procedure: Selective Laser Trabeculoplasty, Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser
360 degrees	Active comparator	Procedure: Selective Laser Trabeculoplasty, Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
greater than 18 years of age
initial intraocular pressure (IOP) of ≥ 21 mmHg

Key exclusion criteria (2 listed)

prior medical or laser therapy to lower IOP
previous incisional glaucoma surgery before the study period

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
Selective Laser TrabeculoplastyAlso: SLTThe procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.	Procedure or surgery	180 degrees, 360 degrees
Neodymium:Yttrium Aluminum Garnet (YAG) laserAlso: Nd:YAG laserThe procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.	Device	180 degrees, 360 degrees

Primary outcome

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up
Time frame: 3 months
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up

3 secondary outcomes

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up
Time frame: 1 year
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required
Time frame: within 1 year of study intervention
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up
Time frame: within 1 year of study intervention

Results and safety

Results posted to the registry on 5 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
180 Degrees	38	38
360 Degrees	38	36

Primary outcome: Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up

Time frame: 3 months. Mean (Standard Deviation). Unit: mm Hg

Measure	180 Degrees n = 38	360 Degrees n = 36
Value	20.7 (5.4)	19.1 (4.1)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
180 Degrees	0 of 38 (0%)	0 of 38 (0%)	0 of 38
360 Degrees	0 of 36 (0%)	1 of 36 (2.8%)	0 of 36

Limitations and caveats (from the sponsor): There were some limitations to this study that include: No standardized definition of who needed laser; No standardized technique other than the amount of meshwork lasered; No standardized IOP checking device; No standardized post op drop regimen; No standardized follow up interval.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Open Angle Glaucoma

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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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.

Jeffrey D. Henderer, MD principal investigator

Temple University

Sophia Siu, MD study director

Temple University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 2 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up (time frame: 3 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 NCT02628223.

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 5 Nov 2020; AzTrials last refreshed its copy on 1 Nov 2026.