NCT02231515

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

August 22, 2014

Last Update Submit

May 16, 2023

Conditions

Glaucoma and Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • • 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 Outcomes (2)

  • o 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

    1 Month

Other Outcomes (1)

  • • CLS derived parameters including: o Wake-to-Sleep slopes, as measured by the linear change in IOP from before going to bed to after

    3 and 6 months

Study Arms (2)

Pattern laser trabeculoplasty (PLT)

EXPERIMENTAL

Pattern laser trabeculoplasty

Device: Pattern laser trabeculoplasty (PLT)

Selective laser trabeculoplasty (SLT)

ACTIVE COMPARATOR

Selective laser trabeculoplasty (SLT)

Device: Selective laser trabeculoplasty (SLT)

Interventions

Selective laser trabeculoplasty (SLT)DEVICE

Selective laser trabeculoplasty

Selective laser trabeculoplasty (SLT)
Pattern laser trabeculoplasty (PLT)DEVICE

Pattern laser trabeculoplasty (PLT)

Pattern laser trabeculoplasty (PLT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genève, Ophtalmology Department

Geneva, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 35943114DERIVED

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Kaweh Mansouri

    Ophtalmology department - Hôpitaux Universitaires de Genève

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 22, 2014

First Posted

September 4, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

CH(1)