Not yet recruiting NCT07174401
Rocklatan Retinal Perfusion OCT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months., Two optical coherence tomography (OCT) devices will be used to assess blood flow changes..
- Who it may be relevant to
- Registry conditions: Glaucoma. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Rocklatan Trial With Optical Coherence Tomography Study of Retinal Perfusion
Overview
The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan.
Interventions
- Drug Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.
The eye not selected as the study eye will be used for comparison so both eyes will be imaged with the study devices to assess blood flow changes. - Device Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.
One OCT device is FDA-cleared while the other is still experimental. Both devices assess blood flow in different ways.
Primary outcome measures
- Nerve Fiber Layer Plexus Capillary Density (NFLP CD) [Time frame: From enrollment to end of treatment at 11-12 months]
Secondary outcome measures (1)
- Total Retinal Blood Flow (TRBF) [Time frame: From enrollment to end of treatment at 11-12 months]
Eligibility criteria
Inclusion criteria
- Patients with both eyes with open angle glaucoma.
- Abnormal VF (glaucomatous pattern with PSD abnormal at p<0.05 or GHT outside normal limits) on most recent two clinic visits on chart review
- Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
- Overall average NFL thickness > 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
- NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
- The difference in baseline NFLP-CD between the left and right eye should be less than 5% (% of area).
- IOP >= 17 mm Hg on the most recent two clinic visits (chart review) after monotherapy with latanoprost in both eyes.
Exclusion criteria
- Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
- Age < 21 years at baseline
- Eye disease that could affect VF, NFL thickness, or NFLP (e.g., visually significant cataract, AMD, diabetic retinopathy, and optic neuropathy) at any study visit
- OCT and OCTA scans not meeting quality criteria at baseline
- Inability to cooperate with study procedures
- Inability to commit to the study visits
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Casey Eye Institute - Oregon Health & Science University — Portland
Identifiers
NCT: NCT07174401 · OHSU IRB0029104