Multicentre, Non-randomised Clinical Study Evaluating the Safety and Efficacy of a Cilioscleral Interposition Device (CID) v2.2 in Glaucoma Surgery

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Patient:

• 18 years or older

• Able to understand study requirements

• Able and willing:

‣ To provide written consent on the EC-approved Informed Consent Form,

⁃ To comply with all study requirements, including required study follow-up visits' agenda

• Eye:

• Glaucoma (angle from 1 to 4 according to Schaffer grade), including pseudo exfoliative and pigmentary glaucoma, which meets the following:

‣ Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p\<5% level as defined by the instrument's built-in age-adjusted normative database,

⁃ Glaucoma visual field with -15 \< MD \< 0dB (Humphrey) or 0 \< MD \< 15 dB (Octopus)

• Pharmacological treatments: glaucoma not adequately controlled by 1 to 3 different IOP-lowering medication(s), given each for at least one month prior to Screening,

• IOP:

‣ if using 1 or 2 IOP-lowering medications, IOP is between 18 mmHg and 30 mmHg in the study eye at Screening visit

⁃ if using 3 IOP-lowering medications, IOP is between 18 mmHg and 25 mmHg in the study eye at Screening visit

• Having the indication for glaucoma surgery alone (no concomitant cataract surgery)

• Central Corneal Thickness between 480 to 620 µm

• Gonioscopy confirming normal angle anatomy at site of implantation. Angle anatomy may include Peripheral Anterior Synechiae (PAS) of up to maximum of 3 clock hours if not present parallel to the proposed site of device implantation.

Locations
Other Locations
Spain
Hospital Clínic of Barcelona
RECRUITING
Barcelona
Hospital Clínico San Carlos. Servicio de Oftalmología
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
WITHDRAWN
Madrid
OMIQ Research
RECRUITING
Sabadell
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitario Miguel Servet. Servicio de Oftalmología.
RECRUITING
Zaragoza
Contact Information
Primary
Stephanie JONES
s.jones@cilia.tech
2018146271
Time Frame
Start Date: 2023-03-23
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 29
Treatments
Experimental: Cilioscleral Interposition Device
Any patients corresponding to inclusion / exclusion criteria
Sponsors
Leads: Ciliatech

This content was sourced from clinicaltrials.gov