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OpenTrials
Completed

NCT Number: NCT05900063

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: SLT

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 12, 2023
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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