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

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT05900063
Collaborator
(none)
75
1
29.4
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Jan 1, 2019
    Actual Study Completion Date :
    Jun 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Decrease of 20% or more of the intraocular pressure after surgery [12 months]

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

    Secondary Outcome Measures

    1. Average Decrease of the intraocular pressure after procedure depending of the initial IOP [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

    2. Average Decrease of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure. [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.

    3. Average Decrease of the intraocular pressure after procedure depending on the type of filtering surgery [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

    4. Average Decrease of the intraocular pressure after procedure depending on the type of glaucoma [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05900063
    Other Study ID Numbers:
    • SLT
    First Posted:
    Jun 12, 2023
    Last Update Posted:
    Jun 12, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Groupe Hospitalier Paris Saint Joseph
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 12, 2023