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

Primary Open-angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04519814
• Other study ID #: T1703PM
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: October 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Post-operative intraocular pressure (IOP) in mmHg	Outcome Parameters Safety: Post-operative intraocular pressure (IOP) in mmHg: 1h, 1d	one (1) day
Other	Rate of intraoperative Adverse Device Effects	Outcome Parameters Safety: Rate of intraoperative Adverse Device Effects	one (1) day
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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