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Optimal Treatment Protocol for Selective Laser Trabeculoplasty (OSLT)

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ClinicalTrials.gov Identifier: NCT03798223
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Vastra Gotaland Region

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Pseudoexfoliation Glaucoma Ocular Hypertension Procedure: SLT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The treatment protocol is masked for the patient and for the nurses conducting measures of intraocular pressure during follow-up.
Primary Purpose: Treatment
Official Title: Optimal Treatment Protocol for Selective Laser Trabeculoplasty
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 180/low
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.
Procedure: SLT
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).

Experimental: 180/high
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.
Procedure: SLT
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).

Experimental: 360/low
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.
Procedure: SLT
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).

Experimental: 360/high
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.
Procedure: SLT
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 Measures :
  1. Change in intraocular pressure (IOP) [ Time Frame: Before SLT and thereafter regularly for 3 years ]

    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.


  2. Achievement of 20% reduction in IOP [ Time Frame: For 3 years ]
    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.

  3. Survival (no additional intervention) [ Time Frame: For 3 years ]
    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 :
  1. Survival (SLT allowed) [ Time Frame: For 3 years ]
    See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure.

  2. Survival (no surgery) [ Time Frame: For 3 years ]
    See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment or change in medical treatment will not be judged as failure.

  3. Pain perioperatively: on a scale [ Time Frame: Immediately after treatment ]
    The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.

  4. Pain postoperatively: on a scale [ Time Frame: During the first month ]
    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.

  5. Light sensitivity postoperatively [ Time Frame: During the first month ]
    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.

  6. Impairment of vision postoperatively [ Time Frame: During the first month ]
    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.

  7. Redness postoperatively [ Time Frame: During the first month ]
    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.

  8. Flare (inflammation measurement of the anterior chamber) [ Time Frame: Pre-operatively and then one day, one week and one month post-operatively. ]
    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.

  9. Adverse events [ Time Frame: 3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks). ]
    The type and frequency of adverse events will be recorded and analyzed in each of the study arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03798223


Locations
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Sweden
Ogonkliniken, Sodra Alvsborgs Sjukhus
Boras, Vastra Gotaland, Sweden, 50182
Ogonkliniken, Sahlgrenska Universitetssjukhuset
Molndal, Vastra Gotaland, Sweden, 43130
Ogonkliniken, Skaraborgs Sjukhus
Skovde, Vastra Gotaland, Sweden, 54142
Ogonkliniken NU-sjukvarden
Uddevalla, Vastra Gotaland, Sweden, 45153
Sponsors and Collaborators
Vastra Gotaland Region
Göteborg University
Investigators
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Study Chair: Marcelo Ayala, MD, PhD Vastra Gotaland Region
Principal Investigator: Tobias Dahlgren, MD Vastra Gotaland Region

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03798223     History of Changes
Other Study ID Numbers: Optimal SLT
254861 ( Other Identifier: FoU i VGR ID nr )
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: December 2018
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
Keywords provided by Vastra Gotaland Region:
Selective Laser Trabeculoplasty
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Exfoliation Syndrome
Eye Diseases
Iris Diseases
Uveal Diseases