Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery
- Conditions
- Glaucoma
- Registration Number
- NCT05900063
- Lead Sponsor
- Fondation Hôpital Saint-Joseph
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change 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
Name Time Method Average change 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 devicesAverage change 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\<21mmHgAverage change 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.Average change 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
Trial Locations
- Locations (1)
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, Ile-de-France, France