Feasibility Clinical Evaluation of the Calibreye System
NCT ID: NCT05885022
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-05-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Investigational Device Arm
Subjects will receive a Calibreye glaucoma device (permanent implant)
Calibreye System
Implantation of a glaucoma device to reduce intraocular pressure
Interventions
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Calibreye System
Implantation of a glaucoma device to reduce intraocular pressure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg
* Visual field mean deviation score of -3dB or worse
* Area of healthy, free and mobile conjunctiva in the target quadrant
* Shaffer angle grade ≥ 3 in the target quadrant
Exclusion Criteria
* Congenital, neovascular or other secondary glaucomas
* Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring \> 3 months prior to the preoperative visit)
* Previous glaucoma shunt/valve in the target quadrant
* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit
* History of corneal surgery, corneal opacities or corneal disease
* Active diabetic retinopathy
18 Years
ALL
Yes
Sponsors
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Myra Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Keith Barton, MD
Role: STUDY_CHAIR
Moorfields Eye Hospital NHS Foundation Trust
Locations
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Dr. Agarwal's Eye Hospital Ltd.
Chennai, , India
Centro Oftalmologico de Chihuahua
Chihuahua City, , Mexico
Oftalmología Láser de Puebla S.C.
Puebla City, , Mexico
Panama Eye Center
Panama City, , Panama
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CFP-101, CFP-103
Identifier Type: -
Identifier Source: org_study_id
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