Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery (SLT)

June 28, 2023 updated by: Groupe Hospitalier Paris Saint Joseph
Glaucoma is a common, potentially blinding pathology, threatening patients' autonomy and quality of life. The main aim of treatment is to lower intraocular pressure (IOP) in order to slow nerve fiber loss as much as possible, leading to alterations in the visual field and even reduced visual acuity. To achieve this drop in pressure, there are, of course, hypotonizing eye drops, trabeculoplasty with Laser Selecta (SLT) or filtering surgery (trabeculectomy, deep non-perforating sclerectomy, insertion of drainage devices). Laser Selecta specifically targets pigmented trabecular meshwork cells without damaging adjacent structures, and is thought to act via three mechanisms: distension of Schlemm's canal, reorganization of trabecular meshwork cells and stimulation of extracellular matrix production. Its efficacy has been demonstrated in several studies, with a 20-30% reduction in intraocular pressure in patients who have never undergone surgery. Few studies have investigated the efficacy of SLT in patients who have already undergone filtering surgery. The aim of this study is therefore to determine the efficacy of SLT in previously operated patients whose intraocular pressure remains insufficiently controlled.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patient undergoind SLT with insufficiently controlled IOP after filtering surgery

Description

Inclusion Criteria:

  • Patients aged ≥ 18 years
  • Patients who have undergone filtering surgery such as trabeculectomy, deep non-perforating sclerectomy, or placement of a Xen®-type device
  • Patients who have undergone laser SLT
  • Patient with primary open-angle glaucoma, exfoliative glaucoma or pigmentary glaucoma
  • Insufficiently controlled intraocular pressure.

Exclusion Criteria: - Patients under guardianship or curatorship

  • Patient deprived of liberty
  • Patient objecting to the use of his or her data for this research
  • Patient with angle-closure glaucoma
  • Patient having undergone any other type of eye surgery except cataract surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the intraocular pressure after surgery
Time Frame: 12 months
Intraocular pressure is measured before procedure , 1 month, 6months and 12 months after procedure
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average change of the intraocular pressure after procedure depending of the initial IOP
Time Frame: 12 months

Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

average IOP decrease is calculated for the group of patients with an initial IOP >21mmHg and for the group with an initial IOP<21mmHg
12 months
Average change of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure.
Time Frame: 12 months

Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

average IOP decrease is calculated for the group of patients with a less than 1 year between filtering surgery and SLT , the group with a period of 1 to 5 years between filtering surgery and SLT and the group with more than 5 year inbetween.
12 months
Average change of the intraocular pressure after procedure depending on the type of filtering surgery
Time Frame: 12 months

Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

average IOP decrease is calculated for each type of filtering surgery : trabeculectomy or, deep non-perforating sclerectomy, or insertion of drainage devices
12 months
Average change of the intraocular pressure after procedure depending on the type of glaucoma
Time Frame: 12 months

Intraocular pressure is measured before procedure , 1 month, 6months and 12 months.

average IOP decrease is calculated for each type of glaucoma : primary open-angle glaucoma, or exfoliative glaucoma or pigmentary glaucoma
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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