Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty

NCT02375009 | Completed DMC

• 1 other identifier: 1411505682
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (3)

• 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

  12 months

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

  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)

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

  12 months

Secondary Outcomes (2)

• 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)

  Through up to five years of follow-up

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

  through up to five years of follow-up

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

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

Selective laser trabeculoplasty PROCEDURE

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

Treatment Cohort

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Eye Institute

Morgantown, West Virginia, 26505, United States

Location

Related Publications (2)

• 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.

  PMID: 33836987 DERIVED

• 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.

  PMID: 29965865 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Tony Realini, MD, MPH

  West Virginia University Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

US (1)