Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Open-angle Glaucoma
• Intervention / Treatment: Procedure: selective laser trabeculoplasty (SLT)

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • Klinik und Poliklinik für Augenheilkunde, TU Dresden
  • Düsseldorf, Germany
    • Internationale Innovative Ophthalmochirurgie GbR
  • Kiel, Germany
    • Augenarztpraxis am Dreiecksplatz, Kiel
  • Kiel, Germany
    • Klinik für Augenheilkunde, UK Schleswig Holstein
  • Rheine, Germany
    • Augentagesklinik Rheine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Congenital glaucoma in either eye
• Diabetic retinopathy or branch retinal vein occlusion with the risk to develop neovascularizations in either eye
• Heavily pigmented trabecular meshwork due to pseudoexfoliation syndrome or pigment dispersion glaucoma in either eye
• Degenerative disorders of the central nervous system if it prevents proper compliance or the ability to undergo the tests in the clinical investigation (e.g. Parkinson Disease, Alzheimer Disease, or other forms of dementia)
• History of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia)
• Patients who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
• Enrollment in another drug or device study within the prior 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: all eligible patients; A total of 40 eyes in 40 consecutive patients, 22 years of age or older, with primary open-angle glaucoma (HPG + NPG), who did not reach target pressure, agree to participate in the study, and will be able to complete clinical follow-up and evaluation.

Procedure: selective laser trabeculoplasty (SLT); Treatment will be performed on Day 0 using the VISULAS green with Option CSLT for SLT treatment and a mirror goniolens to visualize the trabecular meshwork. The initial energy level is set according to the grade of angle pigmentation and bubble formation. Approximately one hundred non-overlapping lesions will be applied in a single session to 360° of the trabecular meshwork.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean absolute change in intraocular pressure (IOP) compared to baseline at month 1	The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 1	one (1) month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean relative change in intraocular pressure (IOP) compared to baseline at month 1	The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 1	one (1) month
mean absolute change in intraocular pressure (IOP) compared to baseline at month 3	The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 3	three (3) months
mean relative change in intraocular pressure (IOP) compared to baseline at month 3	The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 3	three (3) months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of patients achieving >0 to <10% IOP reduction from baseline	The following exploratory endpoint will be determined additionally: - rate of patients achieving >0 to <10% IOP reduction from baseline at 1 and 3 months	three (3) month
rate of patients achieving 10% to <20% IOP reduction from baseline	The following exploratory endpoint will be determined additionally: - rate of patients achieving 10% to <20% IOP reduction from baseline at 1 and 3 months	three (3) month
rate of patients achieving ≥20% IOP reduction from baseline	The following exploratory endpoints will be determined additionally: - rate of patients achieving ≥20% IOP reduction from baseline at 1 and 3 months.	three (3) month
Post-operative intraocular pressure (IOP) in mmHg	Outcome Parameters Safety: Post-operative intraocular pressure (IOP) in mmHg: 1h, 1d	one (1) day
Rate of intraoperative Adverse Device Effects	Outcome Parameters Safety: Rate of intraoperative Adverse Device Effects	one (1) day
Rate of Adverse Device Effects and Device Deficiencies	Outcome Parameters Safety: Rate of Adverse Device Effects and Device Deficiencies over the entire course of the investigation	three (3) month
Rate of Adverse Events and Severe Adverse Events	Outcome Parameters Safety: Rate of Adverse Events and Severe Adverse Events over the entire course of the clinical investigation	three (3) month

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: T1703PM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No