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CompletedNCT02375009Updated Jun 18, 2021

Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty

An interventional study of Selective laser trabeculoplasty in Glaucoma, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by West Virginia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Not applicable
Ages
30 Years and older
Sex
All
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Study summary

This proposal aims to evaluate selective laser trabeculoplasty (SLT) as a safe and effective therapy to control open-angle glaucoma and reduce the risk of progression to visual dysfunction or blindness in the African-derived developing world. If funded, this work will complete the characterization of SLT's safety and efficacy profile as a means of long-term disease control in this population. This work will support the translation of SLT into a structured public health initiative to reduce glaucoma-related vision loss throughout the African-derived developing world.

Read the detailed description

Glaucoma is a leading cause of blindness in the African-derived developing world and represents a significant public health challenge as the disease burden is substantial. In Ghana, the prevalence of open-angle glaucoma over age 40 is 8.5%. In Barbados, the prevalence is 7.0%. In neighboring St. Lucia, the prevalence has been estimated at 8.8% with a 16% ten-year incidence of glaucoma-related blindness in one or both eyes. (In contrast, the prevalence in US adults is 1.9%.) The burden of glaucoma-related visual dysfunction is also substantial in the developing world. Because the application of medical and surgical therapies is limited by issues such as cost, availability, and limited regional surgical expertise, undertreatment is pervasive. Also, there is little access to low vision or vision rehabilitation services and minimal social support for the visually impaired. Laser trabeculoplasty may be a part of the solution to the developing world's burgeoning glaucoma burden. The treatment is fast, safe, minimally invasive and requires minimal post-treatment care; the equipment is portable; and the incremental cost of trabeculoplasty treatment is small once the equipment and expertise are on-site. Our recent study in St. Lucia demonstrated that laser trabeculoplasty lowers IOP by an amount likely to favorably alter the clinical course of glaucoma (versus no treatment) and has the potential to bend the glaucoma-related blindness curve in the African-derived developing world. Our long-term goal is to translate this finding through a public health initiative by establishing a pan-Caribbean glaucoma laser program to provide safe, effective, and cost-effective therapy for glaucoma in this underserved and overburdened region. Before this can happen, several important research questions remain unanswered regarding SLT in this population and comprise the specific aims of this proposal. What is the long-term efficacy of SLT in this population? Is repeat SLT effective once the IOP reduction of initial SLT wanes? Are the results obtained in St. Lucia generalizable to other developing nations populated by people of African descent? In this application, we propose a prospective cohort study in St. Lucia in which qualifying subjects with open-angle glaucoma will receive bilateral selective laser trabeculoplasty, will be followed to failure of initial SLT, and will undergo repeat SLT and again be followed to failure. The long-term safety and efficacy of both initial and repeat SLT in glaucoma patients of African descent will thus be established. Further, we will replicate the cohort study in Dominica to confirm external validity of the St. Lucia outcomes. This proposal is designed to answer the questions posed above and thus to complete the research phase of this project and facilitate translation of the research findings into the public health space. Considering the population of the African-derived developing world, the prevalence of glaucoma in this population, and the observed preliminary benefits of laser therapy, this project's output could ultimately reduce the risk of glaucoma-related visual dysfunction in hundreds of thousands of individuals throughout the developing world.

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Conditions studied

  • Glaucoma

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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 129 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Afro-Caribbean ancestry
  • Ages 30 and above
  • Open-angle glaucoma (ISGEO criteria)
  • CDR≥0.7 or CDR asymmetry ≥0.2 or rim width ≤0.1 CDR with typical VF loss; or
  • CDR≥0.8 or CDR asymmetry ≥0.3 (if unable to get VF); or
  • VA \<20/400 and IOP ≥ 32 mmHg (if unable to get VF or CDR)
  • Receiving ≤2 topical IOP-lowering medications
  • IOP between 17-35 mmHg in both eyes after 30-day washout

Exclusion criteria

Exclusion Criteria:

  • Any glaucoma other than open-angle glaucoma
  • Advanced glaucoma (CDR > 0.9 or field loss in central 10º)
  • History of:
  • Prior glaucoma laser or surgery
  • Ocular inflammation within 3 months
  • Ocular trauma or intraocular surgery within 6 months
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    Treatment Cohort

    All subjects will receive bilateral 360 degree Selective Laser Trabeculoplasty therapy in a single session, but will be randomized to one of three treatment sessions at times 0, Month 3 and Month 6. Subjects will be washed out of current IOP-lowering therapy 4-6 weeks pre-SLT. Subjects continuing on meds beyond time 0 will provide a comparator to early SLT to quantify regression to the mean.

    Procedure: Selective laser trabeculoplasty

Interventions

  • ProcedureSelective laser trabeculoplasty

    laser therapy to trabecular outflow pathway of the eye to lower intraocular pressure, delivered to 360 degrees of both eyes in a single session

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What researchers measure

Primary outcomes

  1. Probability of 12-month success (Proportion of subjects with 20% or greater IOP reduction 12 months following SLT)

    Proportion of subjects with 20% or greater IOP reduction 12 months following SLT

    Time frame: 12 months

  2. Repeat probability of 12-month success (Proportion of subjects with 20% or greater IOP reduction from baseline 12 months after repeat SLT)

    Time frame: 12 months after as-needed repeat SLT

  3. Generalizability of IOP-lowering efficacy to populations other than St. Lucia (significance of a site term in a predictive model of IOP reduction)

    Evaluate significance of a site term in a predictive model of IOP reduction following SLT to determine if response to IOP is site dependent

    Time frame: 12 months

Secondary outcomes

  1. Median survival time following initial SLT (Time from initial SLT to when 50% of subjects no longer manifest a 20% or greater reduction in IOP from baseline)

    Time from initial SLT to when 50% of subjects no longer manifest a 20% or greater reduction in IOP from baseline

    Time frame: Through up to five years of follow-up

  2. Mean IOP reduction (Descriptive analysis of mean (+/- SD) IOP reductions from baseline)

    Descriptive analysis of mean (+/- SD) IOP reductions from baseline at each 12-month period following initial and repeat SLT, separately

    Time frame: through up to five years of follow-up

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Study locations

1 site
  • West Virginia University Eye Institute
    Morgantown, West Virginia 26505, United States
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References and documents

Publications

  • Realini T, Shillingford-Ricketts H, Burt D, Balasubramani GK. Clinical outcomes following selective laser trabeculoplasty in Afro-Caribbean patients with glaucoma at high risk for progression. Br J Ophthalmol. 2022 Sep;106(9):1235-1239. doi: 10.1136/bjophthalmol-2020-317117. Epub 2021 Apr 9. PubMed 33836987 ↗
  • Realini T, Shillingford-Ricketts H, Burt D, Balasubramani GK. West Indies Glaucoma Laser Study (WIGLS)-2: Predictors of Selective Laser Trabeculoplasty Efficacy in Afro-Caribbeans With Glaucoma. J Glaucoma. 2018 Oct;27(10):845-848. doi: 10.1097/IJG.0000000000001018. PubMed 29965865 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02375009
Lead sponsor
West Virginia University
Responsible party
Anthony Realini (Associate Professor of Ophthalmology, West Virginia University) — Principal investigator
First posted
Mar 2, 2015
Start date
Mar 2015
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Jun 18, 2021

Study contacts

Tony Realini, MD, MPH
principal investigator · West Virginia University Eye Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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