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

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ClinicalTrials.gov Identifier: NCT03750201
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
European Commission
Universita degli Studi di Genova
Queen's University, Belfast
Moorfields Eye Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Belkin Laser Ltd.

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.


Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Device: Direct Selective Trabeculoplasty Device: Selective Trabeculoplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Intra-ocular pressure (IOP) measurements by masked investigator or masked technique (masked reading).
Primary Purpose: Treatment
Official Title: Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Direct Selective Trabeculoplasty
Treatment by the investigational device.
Device: Direct Selective Trabeculoplasty
Laser surgery by automated direct automated SLT device to lower intraocular pressure

Active Comparator: Selective Trabeculoplasty
Treatment by the comparator device.
Device: Selective Trabeculoplasty
Laser surgery by standard SLT device to lower intraocular pressure




Primary Outcome Measures :
  1. The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment [ Time Frame: 6 months ]
    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 :
  1. Mean percentage reduction in IOP after the treatment [ Time Frame: 3, 6, and 12 months ]
    Mean percentage reduction in IOP from the baseline will be assessed

  2. Number of medications as compare to screening visit [ Time Frame: 12 months ]
    Number of medications at 12 months as compared to screening/Visit 1 (before treatment) and compared between groups.


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: 6,12 months ]
    Adverse events collection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 less 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 less than -12dB in the fellow eye
  9. Cup:Disc Ratio of more than 0.8
  10. More than two 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750201


Contacts
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Contact: Maital Ben-Hur +972544534308 Maital@belkin-laser.com

Locations
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Israel
Soroka Medical Center Not yet recruiting
Be'er Sheva, Israel
Contact: Mor Portnikov       MorPo@clalit.org.il   
Principal Investigator: Assaff Kratz, Dr         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Meital Abecassis       m_abecassis@rambam.health.gov.il   
Principal Investigator: Eytan Blumenthal, Prof         
Wolfson Medical Center Not yet recruiting
Holon, Israel
Contact: Elizabeth Drozdov       Elizabethd@wmc.gov.il   
Principal Investigator: Maya Kalev - Lindoy, Dr         
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Hila Givoni       hilag@szmc.org.il   
Principal Investigator: Zohar Bracha, Dr         
Rabin Medical Center Recruiting
Petah-Tikva, Israel
Contact: Vivi Dagan    03-9377199    eyeclinic@clalit.org.il   
Principal Investigator: Noa Geffen, Prof         
Italy
Universita degli Studi di Genova Recruiting
Genova, Italy
Contact: Maura Cavo    +3901035338290    mauracavo@alice.it   
Contact: Luca Bagnasco, PhD         
Principal Investigator: Carlo E Traverso, MD         
United Kingdom
Queens University Belfast Recruiting
Belfast, United Kingdom
Contact: Lucia Dalton    07768 858583    L.Dalton@qub.ac.uk   
Principal Investigator: Augusto Azuara-Blanco, PhD,FRCOphth         
Moorfields Eye Hospital Recruiting
London, United Kingdom, EC1V 2PD
Contact: Reem Deib    0207 566 2821    reem.deib@nhs.net   
Principal Investigator: Gus Gazzard, Prof.         
Sponsors and Collaborators
Belkin Laser Ltd.
European Commission
Universita degli Studi di Genova
Queen's University, Belfast
Moorfields Eye Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Nathan Congdon, MD, MPH Queens University Belfast
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Responsible Party: Belkin Laser Ltd.
ClinicalTrials.gov Identifier: NCT03750201    
Other Study ID Numbers: GLAUrious-2017-01
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases