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Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty

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ClinicalTrials.gov Identifier: NCT02375009
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Anthony Realini, West Virginia University

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • Probability of 12-month success (Proportion of subjects with 20% or greater IOP reduction 12 months following SLT) [ Time Frame: 12 months ]
    Proportion of subjects with 20% or greater IOP reduction 12 months following SLT
  • 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 ]
  • Generalizability of IOP-lowering efficacy to populations other than St. Lucia (significance of a site term in a predictive model of IOP reduction) [ Time Frame: 12 months ]
    Evaluate significance of a site term in a predictive model of IOP reduction following SLT to determine if response to IOP is site dependent
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • 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 Frame: Through up to five years of follow-up ]
    Time from initial SLT to when 50% of subjects no longer manifest a 20% or greater reduction in IOP from baseline
  • Mean IOP reduction (Descriptive analysis of mean (+/- SD) IOP reductions from baseline) [ Time Frame: through up to five years of follow-up ]
    Descriptive analysis of mean (+/- SD) IOP reductions from baseline at each 12-month period following initial and repeat SLT, separately
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty
Official Title  ICMJE Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Procedure: Selective 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
Study Arms  ICMJE 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.
Intervention: Procedure: Selective laser trabeculoplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2016)
129
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2015)
120
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375009
Other Study ID Numbers  ICMJE 1411505682
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Anthony Realini, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tony Realini, MD, MPH West Virginia University Eye Institute
PRS Account West Virginia University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP