Glaucoma and Ocular Hypertension
Conditions
Keywords
glaucoma, selective laser trabeculoplasty, clinical trial
Brief summary
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.
Interventions
PROCEDURELow Energy SLT
SLT performed at low energy
PROCEDUREStandard Energy SLT
SLT performed at standard energy
Sponsors
University of Pittsburgh
National Eye Institute (NEI)
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The COAST trial underwent a design modification in response to a planned interim analysis. The original and current designs are described here. Initial Design: Subjects are randomized at study entry to initial SLT at standard or low energy. Subjects who reach Month 12 without discontinuing study treatment are randomized a second time to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48. Current deign: Subjects receive standard at SLT at study entry. Subjects who reach Month 12 without discontinuing study treatment are randomized to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older and in good health 2. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes): 1. 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) 2. 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) 3. 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). 3. Each eye with BCVA 20/200 (UK 6/60) or better
Exclusion criteria
1. 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 enrollment) 2. Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure 3. Advanced POAG in either eye (worse than moderate POAG as defined above) 4. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye 5. Mean IOP \> 35 mmHg at either the screening or baseline visit in either eye 6. Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye 7. Contraindications to SLT or any other study intervention 8. Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye 9. Any intraocular surgical procedure within the past 6 months in either eye 10. Inability to attend all scheduled study visits 11. Pregnant or planning to become pregnant in the next 4 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month survival | 12 months | Survival of first SLT through Month 12 |
| 48-month survival | 48 months | At Month 12, subjects are randomized to repeat SLT either annually at low energy or PRN at standard energy. The proportion controlled with SLT alone at Month 48 will be compared between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean IOP | 12 months | Mean IOP at month 12 |
| Long-term mean IOP | 12, 24, 36, and 48 months | Mean IOP at each study visit |
| Incidence of IOP spikes | 0, 12, 24, 36, and 48 months | IOP spikes \> 5 mmHg on day of SLT |
Countries
Canada, United States
Contacts
CONTACTTony Realini, MD, MPH
STUDY_CHAIRTony Realini, MD, MPH
West Virginia University
PRINCIPAL_INVESTIGATORGoundappa K Balasubramani, PhD
University of Pittsburgh
PRINCIPAL_INVESTIGATORStephen Wisniewski, PhD
University of Pittsburgh
Outcome results
None listed