Clinical trial NCT05900063: Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery
Official title: Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: glaucoma
laser Selecta
trabeculectomy
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoind SLT with insufficiently controlled IOP after filtering surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of the intraocular pressure after surgery
timeFrame: 12 months
Secondary outcomes:
measure: Average change of the intraocular pressure after procedure depending of the initial IOP
timeFrame: 12 months
measure: Average change of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure.
timeFrame: 12 months
measure: Average change of the intraocular pressure after procedure depending on the type of filtering surgery
timeFrame: 12 months
measure: Average change of the intraocular pressure after procedure depending on the type of glaucoma
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
citation: Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. doi: 10.1016/s0014-4835(05)80093-4.
citation: Nagar M, Luhishi E, Shah N. Intraocular pressure control and fluctuation: the effect of treatment with selective laser trabeculoplasty. Br J Ophthalmol. 2009 Apr;93(4):497-501. doi: 10.1136/bjo.2008.148510. Epub 2008 Dec 23.
citation: Zhang H, Yang Y, Xu J, Yu M. Selective laser trabeculoplasty in treating post-trabeculectomy advanced primary open-angle glaucoma. Exp Ther Med. 2016 Mar;11(3):1090-1094. doi: 10.3892/etm.2015.2959. Epub 2015 Dec 29.
citation: Sharpe RA, Kammerdiener LL, Williams DB, Das SK, Nutaitis MJ. Efficacy of selective laser trabeculoplasty following incisional glaucoma surgery. Int J Ophthalmol. 2018 Jan 18;11(1):71-76. doi: 10.18240/ijo.2018.01.13. eCollection 2018.