Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
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: Bimatoprost Implant System, SpyGlass IOL, Timolol Maleate Ophthalmic Solution, 0.5%, Commercial IOL.
- Who it may be relevant to
- Registry conditions: Cataract, Glaucoma, Ocular Hypertension. Basic parameters: from 22 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 →
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Official title
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
Overview
This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
Interventions
- Drug Bimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL - Device SpyGlass IOL
SpyGlass Intraocular Lens - Drug Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID - Device Commercial IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Primary outcome measures
- Mean IOP Reduction from Baseline (mmHg) [Time frame: Weeks 2 and 6, and Month 3]
- BCDVA 20/40 or better [Time frame: Month 6]
Secondary outcome measures (1)
- Mean IOP Reduction from Baseline (mmHg) [Time frame: Month 6, 9 and 12]
Eligibility criteria
Inclusion criteria
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- Planned removal of cataract
- Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception
Exclusion criteria
- Uncontrolled systemic disease
- History of incisional/refractive corneal surgery
- Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma
- History of incisional glaucoma surgery or intraocular injections
- Other ocular diseases, pathology, or conditions
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
- Houston Eye Associates — Houston
Identifiers
NCT: NCT07218783 · SGP-005