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The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study

Primary Purpose

Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Direct Selective Laser Trabeculoplasty (DSLT)
Selective Laser Trabeculoplasty (SLT)
Sponsored by
BelkinVision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic 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 or ≤35mmHg (after washout of any IOP-lowering medications) for participants with open angle glaucoma or IOP ≥ 24mmHg to ≤35mmHg (after washout of any IOP-lowering medications) for participants with ocular hypertension
  4. Gonioscopically visible scleral spur for 360 degrees without indentation
  5. Ability to visualize the peri-limbal sclera for 360 degrees (using a 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. Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
  6. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye

  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 more than 0.8
  10. More than three hypotensive medications required (combination drops are considered 2 medications)
  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 course of 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, not including a GLAUrious sub-study

Sites / Locations

  • Akhali Mzera Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Direct Selective Laser Trabeculoplasty (DSLT)

Selective Laser Trabeculoplasty (SLT)

Arm Description

Direct Selective Laser Trabeculoplasty (DSLT): employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus.

SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area).

Outcomes

Primary Outcome Measures

Difference between the mean baseline and 6 month central corneal thickness, DSLT vs SLT
Central corneal thickness will be assessed by pachymetry
Difference between the mean baseline and 6 month corneal endothelial cell count, DSLT vs SLT
Corneal endothelial cell count will be assessed with specular microscopy

Secondary Outcome Measures

Full Information

First Posted
February 11, 2021
Last Updated
January 13, 2023
Sponsor
BelkinVision
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1. Study Identification

Unique Protocol Identification Number
NCT04758598
Brief Title
The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study
Official Title
The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BelkinVision

4. Oversight

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

5. Study Description

Brief Summary
The objective of this study is to compare the long-term (6 months) effects of Direct Selective Laser Trabeculoplasty (DSLT) treatment and SLT (Selective Laser Trabeculoplasty) treatment on corneal endothelial cell counts and corneal thickness.
Detailed Description
Rational: SLT has known transient effect on corneal endothelial cell (CEC) counts yet no data is yet available with DSLT. This study is relevant as the DSLT treatment area is at the limbus: CEC progenitor site

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
DSLT treatment vs. SLT treatment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Selective Laser Trabeculoplasty (DSLT)
Arm Type
Experimental
Arm Description
Direct Selective Laser Trabeculoplasty (DSLT): employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus.
Arm Title
Selective Laser Trabeculoplasty (SLT)
Arm Type
Active Comparator
Arm Description
SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area).
Intervention Type
Device
Intervention Name(s)
Direct Selective Laser Trabeculoplasty (DSLT)
Intervention Description
DSLT employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus.
Intervention Type
Device
Intervention Name(s)
Selective Laser Trabeculoplasty (SLT)
Intervention Description
SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area).
Primary Outcome Measure Information:
Title
Difference between the mean baseline and 6 month central corneal thickness, DSLT vs SLT
Description
Central corneal thickness will be assessed by pachymetry
Time Frame
6 months
Title
Difference between the mean baseline and 6 month corneal endothelial cell count, DSLT vs SLT
Description
Corneal endothelial cell count will be assessed with specular microscopy
Time Frame
6 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 or ≤35mmHg (after washout of any IOP-lowering medications) for participants with open angle glaucoma or IOP ≥ 24mmHg to ≤35mmHg (after washout of any IOP-lowering medications) for participants with ocular hypertension Gonioscopically visible scleral spur for 360 degrees without indentation Ability to visualize the peri-limbal sclera for 360 degrees (using a 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 Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%) Presence of any Peripheral Anterior Synechiae (PAS) in the study eye 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 more than 0.8 More than three hypotensive medications required (combination drops are considered 2 medications) 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 course of 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, not including a GLAUrious sub-study
Facility Information:
Facility Name
Akhali Mzera Eye Clinic
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We plan to share the protocol, statistical plan and results

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The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study

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