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Optimal Treatment Protocol for Selective Laser Trabeculoplasty (OSLT)

Primary Purpose

Glaucoma, Open-Angle, Pseudoexfoliation Glaucoma, Ocular Hypertension

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SLT
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Selective Laser Trabeculoplasty

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension.
  • intra-ocular pressure (IOP) at least 18 mmHg treatment day.
  • treatment is performed by an experienced laser surgeon.
  • SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient.

Exclusion Criteria:

  • change of IOP-lowering medication during the last three months.
  • planned change of intra-ocular-pressure-lowering medication.
  • previous glaucoma surgery (other than SLT and ALT)
  • previous intra-ocular surgery during the last three months.
  • previous intra-ocular inflammatory disease during the last year.
  • planned intra-ocular surgery.
  • hyper-pigmented anterior chamber angle.

Sites / Locations

  • Ogonkliniken, Sodra Alvsborgs Sjukhus
  • Ogonkliniken, Sahlgrenska Universitetssjukhuset
  • Ogonkliniken, Skaraborgs Sjukhus
  • Ogonkliniken NU-sjukvarden

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

180/low

180/high

360/low

360/high

Arm Description

SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.

SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.

SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

Outcomes

Primary Outcome Measures

Change in intraocular pressure (IOP)
The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures. Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.
Achievement of 20% reduction in IOP
See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.
Survival (no additional intervention)
Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).

Secondary Outcome Measures

Survival (SLT allowed)
See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure.
Pain perioperatively: on a scale
The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.
Pain postoperatively: on a scale
The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain.
Light sensitivity postoperatively
The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity.
Impairment of vision postoperatively
The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment.
Redness postoperatively
The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness.
Flare (inflammation measurement of the anterior chamber)
15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter.
Adverse events
The type and frequency of adverse events will be recorded and analyzed in each of the study arms.

Full Information

First Posted
January 3, 2019
Last Updated
March 6, 2023
Sponsor
Vastra Gotaland Region
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03798223
Brief Title
Optimal Treatment Protocol for Selective Laser Trabeculoplasty
Acronym
OSLT
Official Title
Optimal Treatment Protocol for Selective Laser Trabeculoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Göteborg University

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
A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
Detailed Description
A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use. Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the patient and is coded in the records. The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Pseudoexfoliation Glaucoma, Ocular Hypertension
Keywords
Selective Laser Trabeculoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The treatment protocol is masked for the patient and for the nurses conducting measures of intraocular pressure during follow-up.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
180/low
Arm Type
Experimental
Arm Description
SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.
Arm Title
180/high
Arm Type
Experimental
Arm Description
SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.
Arm Title
360/low
Arm Type
Experimental
Arm Description
SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.
Arm Title
360/high
Arm Type
Experimental
Arm Description
SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.
Intervention Type
Procedure
Intervention Name(s)
SLT
Intervention Description
A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).
Primary Outcome Measure Information:
Title
Change in intraocular pressure (IOP)
Description
The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures. Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.
Time Frame
Before SLT and thereafter regularly for 3 years
Title
Achievement of 20% reduction in IOP
Description
See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.
Time Frame
For 3 years
Title
Survival (no additional intervention)
Description
Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).
Time Frame
For 3 years
Secondary Outcome Measure Information:
Title
Survival (SLT allowed)
Description
See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure.
Time Frame
For 3 years
Title
Pain perioperatively: on a scale
Description
The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.
Time Frame
Immediately after treatment
Title
Pain postoperatively: on a scale
Description
The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain.
Time Frame
During the first month
Title
Light sensitivity postoperatively
Description
The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity.
Time Frame
During the first month
Title
Impairment of vision postoperatively
Description
The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment.
Time Frame
During the first month
Title
Redness postoperatively
Description
The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness.
Time Frame
During the first month
Title
Flare (inflammation measurement of the anterior chamber)
Description
15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter.
Time Frame
Pre-operatively and then one day, one week and one month post-operatively.
Title
Adverse events
Description
The type and frequency of adverse events will be recorded and analyzed in each of the study arms.
Time Frame
3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension. intra-ocular pressure (IOP) at least 18 mmHg treatment day. treatment is performed by an experienced laser surgeon. SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient. Exclusion Criteria: change of IOP-lowering medication during the last three months. planned change of intra-ocular-pressure-lowering medication. previous glaucoma surgery (other than SLT and ALT) previous intra-ocular surgery during the last three months. previous intra-ocular inflammatory disease during the last year. planned intra-ocular surgery. hyper-pigmented anterior chamber angle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Ayala, MD, PhD
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tobias Dahlgren, MD
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ogonkliniken, Sodra Alvsborgs Sjukhus
City
Boras
State/Province
Vastra Gotaland
ZIP/Postal Code
50182
Country
Sweden
Facility Name
Ogonkliniken, Sahlgrenska Universitetssjukhuset
City
Molndal
State/Province
Vastra Gotaland
ZIP/Postal Code
43130
Country
Sweden
Facility Name
Ogonkliniken, Skaraborgs Sjukhus
City
Skovde
State/Province
Vastra Gotaland
ZIP/Postal Code
54142
Country
Sweden
Facility Name
Ogonkliniken NU-sjukvarden
City
Uddevalla
State/Province
Vastra Gotaland
ZIP/Postal Code
45153
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimal Treatment Protocol for Selective Laser Trabeculoplasty

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