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

NCT05900063 | Completed

• 1 other identifier: SLT
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; laser Selecta; trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Change of the intraocular pressure after surgery

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

  12 months

Secondary Outcomes (4)

• Average change of the intraocular pressure after procedure depending of the initial IOP

  12 months

• Average change of the intraocular pressure after procedure depending on the delay between filtering surgery and the Selecta Laser procedure.

  12 months

• Average change of the intraocular pressure after procedure depending on the type of filtering surgery

  12 months

• Average change of the intraocular pressure after procedure depending on the type of glaucoma

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient undergoind SLT with insufficiently controlled IOP after filtering surgery

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

Related 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.

  PMID: 7789416 BACKGROUND

• 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.

  PMID: 19106150 BACKGROUND

• 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.

  PMID: 26998042 BACKGROUND

• 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.

  PMID: 29375994 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 15, 2020
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)