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Prospective,Randomized,Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG

Primary Purpose

Glaucoma and Ocular Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Selective laser trabeculoplasty (SLT)
Pattern laser trabeculoplasty (PLT)
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma and Ocular Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma
  • Patients requiring bilateral laser trabeculoplasty for IOP control
  • Structural glaucomatous damage and/or documented glaucomatous VF damage (in the previous 12 months with mean defect (MD) > 2.5 dB
  • No or stable anti-glaucomatous drug therapy since at least 3 months. Able to undergo medication washout for 4 weeks prior to baseline 24-h IOP monitoring session.
  • Aged ≥18 years, of either sex
  • Not more than 6 diopters spherical equivalent on the study eye
  • Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

  • Refractory glaucoma
  • Patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma.
  • Corneal or conjunctival abnormality precluding contact lens adaptation
  • Severe dry eye syndrome
  • Patients with allergy to corneal anesthetic
  • Patients with contraindications for silicone contact lens wear
  • Patients not able to understand the character and individual consequences of the investigation
  • Participation in other clinical research within the last 4 weeks
  • Any other contra-indication listed in the CLS (SENSIMED Triggerfish) user manual

Sites / Locations

  • Hôpitaux Universitaires de Genève, Ophtalmology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pattern laser trabeculoplasty (PLT)

Selective laser trabeculoplasty (SLT)

Arm Description

Pattern laser trabeculoplasty

Selective laser trabeculoplasty (SLT)

Outcomes

Primary Outcome Measures

• Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Change in IOP from baseline to 1 month post-surgery as measured by tonometry

Secondary Outcome Measures

o Complete success: Reduction of at least 20% in IOP without medication
Complete success: Reduction of at least 20% in IOP without medication
o Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication

Full Information

First Posted
August 22, 2014
Last Updated
May 16, 2023
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT02231515
Brief Title
Prospective,Randomized,Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG
Official Title
A Prospective, Randomized, Controlled Study to Assess Efficacy,Safety, and Tolerability of Selective Laser Trabeculoplasty vs. Pattern Laser Trabeculoplasty in Patients With Open-angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
departure of principal investigator from the organisation
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle glaucoma.
Detailed Description
This is a prospective, randomised, controlled study. Patients will be selected for this study who require bilateral laser trabeculoplasty for IOP control. Eyes will undergo a medication wash-out 4 weeks prior to the baseline study session (S1). There will be a security visit at 2 weeks to make sure that the IOPs remain within a safe range. Following S1 both study eyes will receive laser treatment, as assigned by randomization, within a period of 2 weeks. Eyes will be randomized to receive the SLT (SLT eye) or PLT (PLT eye) treatment. Both laser procedures will be performed in one session (for 360° of the angle), if patients tolerate it. Otherwise, they will be split into two sessions (each treating 180° of the angle) to be performed within 1 week of each other. The same pre- and post-laser procedures will be applied on both eyes. After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. The CLS will be placed on both eyes for a baseline 24-hour IOP pattern recording session (S1), within 2 weeks preceding the laser treatment. Patients will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual lifestyle as possible. At hour 24, patients will return to the clinic, the device will be removed and a final ophthalmic examination will be conducted. Patient diary will be collected and concomitant medication will be reported. Following S1 both study eyes will receive either SLT or PLT laser treatment, as assigned by randomization (1:1), within a period of 2 weeks. The same pre- and post-laser procedures will be applied on both eyes. At S2 (1 month after laser treatment) patients will be randomized to 24-hour CLS recording on either the SLT or on the PLT eye (1:1). The same ophthalmic examinations as during S1 will be conducted and patient diary collected. At month 3 patients will be followed up with a slit lamp examination and IOP measurement. At months 6 and 12, patients will be seen for a complete ophthalmic examination including visual field exam (Octopus, Switzerland), optic nerve and retinal nerve fiber layer evaluation (Spectralis OCT, Germany). The overall study duration for the patient is limited to up to 14 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pattern laser trabeculoplasty (PLT)
Arm Type
Experimental
Arm Description
Pattern laser trabeculoplasty
Arm Title
Selective laser trabeculoplasty (SLT)
Arm Type
Active Comparator
Arm Description
Selective laser trabeculoplasty (SLT)
Intervention Type
Device
Intervention Name(s)
Selective laser trabeculoplasty (SLT)
Intervention Description
Selective laser trabeculoplasty
Intervention Type
Device
Intervention Name(s)
Pattern laser trabeculoplasty (PLT)
Intervention Description
Pattern laser trabeculoplasty (PLT)
Primary Outcome Measure Information:
Title
• Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Description
Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Time Frame
1 month
Secondary Outcome Measure Information:
Title
o Complete success: Reduction of at least 20% in IOP without medication
Description
Complete success: Reduction of at least 20% in IOP without medication
Time Frame
1 month
Title
o Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
Description
Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
Time Frame
1 Month
Other Pre-specified Outcome Measures:
Title
• CLS derived parameters including: o Wake-to-Sleep slopes, as measured by the linear change in IOP from before going to bed to after
Description
CLS derived parameters including:
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma Patients requiring bilateral laser trabeculoplasty for IOP control Structural glaucomatous damage and/or documented glaucomatous VF damage (in the previous 12 months with mean defect (MD) > 2.5 dB No or stable anti-glaucomatous drug therapy since at least 3 months. Able to undergo medication washout for 4 weeks prior to baseline 24-h IOP monitoring session. Aged ≥18 years, of either sex Not more than 6 diopters spherical equivalent on the study eye Have given written informed consent, prior to any investigational procedures Exclusion Criteria: Refractory glaucoma Patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma. Corneal or conjunctival abnormality precluding contact lens adaptation Severe dry eye syndrome Patients with allergy to corneal anesthetic Patients with contraindications for silicone contact lens wear Patients not able to understand the character and individual consequences of the investigation Participation in other clinical research within the last 4 weeks Any other contra-indication listed in the CLS (SENSIMED Triggerfish) user manual
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaweh Mansouri
Organizational Affiliation
Ophtalmology department - Hôpitaux Universitaires de Genève
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Genève, Ophtalmology Department
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35943114
Citation
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Results Reference
derived

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Prospective,Randomized,Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG

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