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

Primary Purpose

Primary Open-angle Glaucoma

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
selective laser trabeculoplasty (SLT)
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all eligible patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
July 22, 2020
Last Updated
July 19, 2022
Sponsor
Carl Zeiss Meditec AG
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1. Study Identification

Unique Protocol Identification Number
NCT04519814
Brief Title
Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
Official Title
A Prospective, Multicenter Clinical Investigation to Evaluate Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all eligible patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
selective laser trabeculoplasty (SLT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean absolute change in intraocular pressure (IOP) compared to baseline at month 1
Description
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 1
Time Frame
one (1) month
Secondary Outcome Measure Information:
Title
mean relative change in intraocular pressure (IOP) compared to baseline at month 1
Description
The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 1
Time Frame
one (1) month
Title
mean absolute change in intraocular pressure (IOP) compared to baseline at month 3
Description
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 3
Time Frame
three (3) months
Title
mean relative change in intraocular pressure (IOP) compared to baseline at month 3
Description
The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 3
Time Frame
three (3) months
Other Pre-specified Outcome Measures:
Title
rate of patients achieving >0 to <10% IOP reduction from baseline
Description
The following exploratory endpoint will be determined additionally: - rate of patients achieving >0 to <10% IOP reduction from baseline at 1 and 3 months
Time Frame
three (3) month
Title
rate of patients achieving 10% to <20% IOP reduction from baseline
Description
The following exploratory endpoint will be determined additionally: - rate of patients achieving 10% to <20% IOP reduction from baseline at 1 and 3 months
Time Frame
three (3) month
Title
rate of patients achieving ≥20% IOP reduction from baseline
Description
The following exploratory endpoints will be determined additionally: - rate of patients achieving ≥20% IOP reduction from baseline at 1 and 3 months.
Time Frame
three (3) month
Title
Post-operative intraocular pressure (IOP) in mmHg
Description
Outcome Parameters Safety: Post-operative intraocular pressure (IOP) in mmHg: 1h, 1d
Time Frame
one (1) day
Title
Rate of intraoperative Adverse Device Effects
Description
Outcome Parameters Safety: Rate of intraoperative Adverse Device Effects
Time Frame
one (1) day
Title
Rate of Adverse Device Effects and Device Deficiencies
Description
Outcome Parameters Safety: Rate of Adverse Device Effects and Device Deficiencies over the entire course of the investigation
Time Frame
three (3) month
Title
Rate of Adverse Events and Severe Adverse Events
Description
Outcome Parameters Safety: Rate of Adverse Events and Severe Adverse Events over the entire course of the clinical investigation
Time Frame
three (3) month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Klinik und Poliklinik für Augenheilkunde, TU Dresden
City
Dresden
Country
Germany
Facility Name
Internationale Innovative Ophthalmochirurgie GbR
City
Düsseldorf
Country
Germany
Facility Name
Augenarztpraxis am Dreiecksplatz, Kiel
City
Kiel
Country
Germany
Facility Name
Klinik für Augenheilkunde, UK Schleswig Holstein
City
Kiel
Country
Germany
Facility Name
Augentagesklinik Rheine
City
Rheine
Country
Germany

12. IPD Sharing Statement

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

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