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Recruiting NCT05885022

Feasibility Clinical Evaluation of the Calibreye System

No phase Interventional Glaucoma, Open-Angle

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: Calibreye System.
Who it may be relevant to
Registry conditions: Glaucoma, Open-Angle. Basic parameters: from 18 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
India, Mexico, Panama
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 →

Overview

To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.

Detailed description

This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.

Interventions

  • Device Calibreye System
    Implantation of a glaucoma device to reduce intraocular pressure

Primary outcome measures

  • Intraocular Pressure [Time frame: 12 Months]
  • Adverse Events [Time frame: 12 Months]
Secondary outcome measures (1)
  • Glaucoma Medication Usage [Time frame: 12 Months]

Eligibility criteria

Inclusion criteria

  • Open angle, pseudoexfoliative or pigmentary glaucoma
  • 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

  • Angle closure glaucoma
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Mexico · 2 centers
  • Centro Oftalmologico de Chihuahua — Chihuahua City
  • Oftalmología Láser de Puebla S.C. — Puebla City
India · 1 center
  • Dr. Agarwal's Eye Hospital Ltd. — Chennai
Panama · 1 center
  • Panama Eye Center — Panama City

Identifiers

NCT: NCT05885022 · CFP-101, CFP-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗