A Prospective, Multicenter Clinical Investigation to Evaluate Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)

Carl Zeiss Meditec AG5 sites in 1 country37 target enrollmentJune 30, 2020

ConditionsPrimary Open-angle Glaucoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Primary Open-angle Glaucoma
Sponsor: Carl Zeiss Meditec AG
Enrollment: 37
Locations: 5
Primary Endpoint: mean absolute change in intraocular pressure (IOP) compared to baseline at month 1
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An interventional, open, prospective, multi-center pre-market clinical investigation according to §§20-23a Medizinproduktegesetz (MPG, medical devices act), in which a total of 40 eyes of 40 consecutive patients at up to five (5) clinical sites will be enrolled, treated with the VISULAS green with option CSLT, and followed for a three months period.

The primary objective of this clinical investigation is to evaluate safety and effectiveness of SLT with the VISULAS green laser with option CSLT.

Registry

clinicaltrials.gov

Start Date

June 30, 2020

End Date

September 13, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Carl Zeiss Meditec AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females at least 22 years of age or older, primary open-angle glaucoma (HPG + NPG), who did not reach target pressure .
•IOP with or without medications ≥17 mmHg in the study eye
•Chamber angle Shaffer 3 and 4
•Patients must be legally competent and able to give consent and must have read, understood and signed patient information leaflet and consent to undergo SLT in one eye
•Patients are willing and able to return for follow-up examinations
•In the opinion of the investigator, the patient will be compliant and have a high probability of completing the clinical investigation and all required procedures

Exclusion Criteria

•Corneal disease or pathology in a way that distortion of laser light in the study eye can be expected or that precludes stabilization of the cornea by the contact glass, visibility of the trabecular meshwork or transmission of laser wavelength
•Strong clouding of the anterior ocular media (e.g. the lens due to dense cataract) and the vitreous body (e.g. due to strong vitreous hemorrhage) in either eye
•Deep orbits and/or narrow palpebral fissures
•Corneal or conjunctival abnormality precluding contact lens adaptation in either eye
•History of Amblyopia in either eye
•Any contraindications to SLT in study eye.
•Any kind of planned ocular surgeries during the next 3 months (for example, cataract surgery) in either eye
•Previous intraocular or corneal surgery of any kind (except cataract surgery longer than three months prior to the clinical investigation), including surgical glaucoma intervention in study eye before the clinical investigation.
•Signs of Fuchs' Dystrophy (e.g. corneal endothelial guttata) in either eye
•Active or history of Uveitis in either eye

Outcomes

Primary Outcomes

mean absolute change in intraocular pressure (IOP) compared to baseline at month 1

Time Frame: one (1) month

The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 1

Secondary Outcomes

mean absolute change in intraocular pressure (IOP) compared to baseline at month 3(three (3) months)
mean relative change in intraocular pressure (IOP) compared to baseline at month 1(one (1) month)
mean relative change in intraocular pressure (IOP) compared to baseline at month 3(three (3) months)