Home/Get Matched/NCT04967989
PHASE3RECRUITING
View on ClinicalTrials.gov

Comparing 4 approaches for glaucoma and ocular hypertension

Official title: Clarifying the Optimal Application of SLT Therapy Trial

Condition: Glaucoma and Ocular HypertensionSponsor: University of PittsburghTarget enrollment: 790

Interventions

PROCEDURE

Low Energy SLT

SLT performed at low energy

PROCEDURE

Standard Energy SLT

SLT performed at standard energy

Canadian Sites (1)

Ocular Health Centre

Kitchener, Ontario, Canada

ACTIVE_NOT_RECRUITING

Eligibility Criteria

See who this study is looking for17 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age 18 or older and in good health
  • +Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
  • +High-risk ocular hypertension (OHT): IOP \> 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of \>0.2 between eyes)
  • +Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5° \<15 dB (see figure on next page)
  • +Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5° points \<15 dB or mean deviation -12.0 dB or better with 1 central 5° points \<15 dB (see figure on next page).
  • +Each eye with BCVA 20/200 (UK 6/60) or better

Exclusion

  • Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years (this is a modification implemented during active enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →)
  • Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
  • Advanced POAG in either eye (worse than moderate POAG as defined above)
  • Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
  • Mean IOP \> 35 mmHg at either the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or baseline visitBaselineYour starting measurements, taken before treatment begins.Read more → in either eye
  • Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
  • Contraindications to SLT or any other study intervention
  • Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
  • Any intraocular surgical procedure within the past 6 months in either eye
  • Inability to attend all scheduled study visits
  • Pregnant or planning to become pregnant in the next 4 years
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

What is being given or done in this study: Low Energy SLT, Standard Energy SLT.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

There are 4 groups in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 790 people.

The study is currently expected to finish around August 2027.

The main measurement is taken over: 12 months.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

12-month survival — measured over 12 months.

48-month survival — measured over 48 months.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04967989 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Low Energy SLTProcedure

SLT performed at low energy

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Standard Energy SLTProcedure

SLT performed at standard energy

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 12 months.

The study as a whole is currently expected to finish around 2027-08-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 790 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 5 locations, including: Kitchener, Ontario, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; The Bronx, New York, United States; Spokane, Washington, United States.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.

Other Sites (4)

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

Kresge Eye Institute Wayne State University

Detroit, Michigan, United States

New York Eye Surgery Associates

The Bronx, New York, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.