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

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

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 Overview

• Status: Terminated
• Conditions: Glaucoma and Ocular Hypertension
• Intervention / Treatment: Device: Pattern laser trabeculoplasty (PLT); Device: Selective laser trabeculoplasty (SLT)

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaweh Mansouri; Phone Number: +41 79 553 38 64; Email: kaweh.mansouri@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Hôpitaux Universitaires de Genève, Ophtalmology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pattern laser trabeculoplasty (PLT); Pattern laser trabeculoplasty	Device: Pattern laser trabeculoplasty (PLT); Pattern laser trabeculoplasty (PLT)
Active Comparator: Selective laser trabeculoplasty (SLT)	Device: Selective laser trabeculoplasty (SLT); Selective laser trabeculoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
o Complete success: Reduction of at least 20% in IOP without medication	Complete success: Reduction of at least 20% in IOP without medication	1 month
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	1 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
• CLS derived parameters including: o Wake-to-Sleep slopes, as measured by the linear change in IOP from before going to bed to after	CLS derived parameters including:	3 and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Kaweh Mansouri, Ophtalmology department - Hôpitaux Universitaires de Genève

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: September 1, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 1219