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

Glaucoma Clinical Trial

— SLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900063
• Other study ID #: SLT
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 15, 2020

Study information

• Verified date: June 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 15, 2020
• Est. primary completion date: January 1, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the intraocular pressure after surgery	Intraocular pressure is measured before procedure , 1 month, 6months and 12 months after procedure	12 months
Secondary	Average change of the intraocular pressure after procedure depending of the initial IOP	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
Secondary	Average change of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure.	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
Secondary	Average change of the intraocular pressure after procedure depending on the type of filtering surgery	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
Secondary	Average change of the intraocular pressure after procedure depending on the type of glaucoma	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