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A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty (GLAUrious)

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Direct Selective Trabeculoplasty
Selective Trabeculoplasty
Sponsored by
BelkinVision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 40 years or older, with visual acuity > 6/60 in both eyes
  2. Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension
  3. IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)
  4. Gonioscopically visible scleral spur for 360 degrees without indentation
  5. Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
  6. Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule
  7. Participant capable of giving informed consent

Exclusion Criteria:

  1. Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc.)
  2. Angle Closure Glaucoma
  3. Congenital or developmental glaucoma
  4. Secondary glaucoma except exfoliative or pigmentary glaucoma
  5. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
  6. Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)

  7. Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:

    1. A visual field MD of worse than -12dB
    2. Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
    3. At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
    4. Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot
  8. A visual field MD of worse than -12dB in the fellow eye
  9. Cup:Disc Ratio of more than 0.8
  10. More than three hypotensive mediations required
  11. Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye
  12. Prior corneal refractive surgery
  13. Complicated cataract surgery ≤ 6 months prior to enrollment
  14. Presence of visually significant cataract in the opinion of the investigator
  15. Clinically significant disease in either eye as determined by the Investigator
  16. Clinically significant amblyopia in either eye
  17. Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
  18. Women who are pregnant or may become pregnant during the study
  19. In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP
  20. Concurrent treatment with topical, nasal, inhaled or systemic steroids
  21. Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
  22. Participation in another clinical study

Sites / Locations

  • Soroka Medical Center
  • Rambam Medical Center
  • Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Rabin Medical Center
  • Universita degli Studi di Genova
  • Queens University Belfast
  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Direct Selective Trabeculoplasty

Selective Trabeculoplasty

Arm Description

Treatment by the investigational device.

Treatment by the comparator device.

Outcomes

Primary Outcome Measures

The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment

Secondary Outcome Measures

Number of medications as compare to screening visit
Number of medications at 6 months as compared to screening/Visit 1 (before treatment) and compared between groups.
Proportion of subjects with at least 20% reduction in IOP from baseline
Proportion of subjects with at least 20% reduction in IOP at 6 months compared to baseline without surgical intervention

Full Information

First Posted
November 19, 2018
Last Updated
January 13, 2023
Sponsor
BelkinVision
Collaborators
European Commission, Universita degli Studi di Genova, Queen's University, Belfast, Moorfields Eye Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03750201
Brief Title
A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty
Acronym
GLAUrious
Official Title
Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BelkinVision
Collaborators
European Commission, Universita degli Studi di Genova, Queen's University, Belfast, Moorfields Eye Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition. Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of fluid from inside the eye. This has the potential of reducing the intraocular pressure within the eye (the main way in which this disease is treated since there is no cure) and may assist in helping to control the progression of this disease. SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes approximately 5 minutes in duration. This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye, and it is a shorter and simpler technique to conduct when compared to the standard SLT technique. The purpose of this study is to assess the hypothesis that the treatment by new automated device for DSLT is not worse in comparison with the standard SLT and determine that it is effective in reducing intraocular pressure.
Detailed Description
Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition. Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is. The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT and determine that it is as effective in reducing intraocular pressure. DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list. The un-masked investigator(s) will open the envelope corresponding to the subject ID and administer the treatment as indicated by the randomization envelope. The masked ophthalmologist(s), who will perform the follow up, will be masked as to the nature of the treatment the patient underwent. Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Intra-ocular pressure (IOP) measurements by masked investigator or masked technique (masked reading).
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Selective Trabeculoplasty
Arm Type
Experimental
Arm Description
Treatment by the investigational device.
Arm Title
Selective Trabeculoplasty
Arm Type
Active Comparator
Arm Description
Treatment by the comparator device.
Intervention Type
Device
Intervention Name(s)
Direct Selective Trabeculoplasty
Intervention Description
Laser surgery by automated direct automated SLT device to lower intraocular pressure
Intervention Type
Device
Intervention Name(s)
Selective Trabeculoplasty
Intervention Description
Laser surgery by standard SLT device to lower intraocular pressure
Primary Outcome Measure Information:
Title
The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
Description
The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of medications as compare to screening visit
Description
Number of medications at 6 months as compared to screening/Visit 1 (before treatment) and compared between groups.
Time Frame
6 months
Title
Proportion of subjects with at least 20% reduction in IOP from baseline
Description
Proportion of subjects with at least 20% reduction in IOP at 6 months compared to baseline without surgical intervention
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events
Description
Rates of Ocular Adverse events (AEs) in each treatment group at or prior to the 12 months visit
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 years or older, with visual acuity > 6/60 in both eyes Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications) Gonioscopically visible scleral spur for 360 degrees without indentation Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum) Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule Participant capable of giving informed consent Exclusion Criteria: Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc.) Angle Closure Glaucoma Congenital or developmental glaucoma Secondary glaucoma except exfoliative or pigmentary glaucoma Presence of any Peripheral Anterior Synechiae (PAS) in the study eye Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%) Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program: A visual field MD of worse than -12dB Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot A visual field MD of worse than -12dB in the fellow eye Cup:Disc Ratio of more than 0.8 More than three hypotensive mediations required Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye Prior corneal refractive surgery Complicated cataract surgery ≤ 6 months prior to enrollment Presence of visually significant cataract in the opinion of the investigator Clinically significant disease in either eye as determined by the Investigator Clinically significant amblyopia in either eye Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera Women who are pregnant or may become pregnant during the study In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP Concurrent treatment with topical, nasal, inhaled or systemic steroids Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator Participation in another clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD, MPH
Organizational Affiliation
Queens University Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Be'er Sheva
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petah-Tikva
Country
Israel
Facility Name
Universita degli Studi di Genova
City
Genova
Country
Italy
Facility Name
Queens University Belfast
City
Belfast
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34433548
Citation
Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136/bjophthalmol-2021-319379. Epub 2021 Aug 25.
Results Reference
derived

Learn more about this trial

A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty

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