Deep Sclerectomy vs Xen in Solo Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2022-10-06

Brief Summary

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Glaucoma is the leading cause of irreversible blindness in the world and the second leading cause of blindness after cataract after the age of 50. Lowering intraocular pressure (IOP) is the only treatment option to prevent visual field degradation. While medical treatment and selective laser trabeculoplasty are considered first-line options in open-angle glaucoma, the surgical option is considered in patients who have uncontrolled IOP under maximal tolerated medical treatment. In this situation, trabeculectomy or deep nonperforating sclerectomy may be performed. Although it is uncertain whether SPNP is superior to trabeculectomy, which is considered the gold standard of surgery, SPNP is a procedure that offers a better quality of life and fewer intra- and postoperative complications. SPNP was first described by Zimmerman. It consists in peeling off the internal wall of Schlemm's canal and the juxta-canalicular trabeculum which represent the main resistances to the evacuation of the aqueous humor. The trabecular meshwork is left intact and acts as a filter membrane between the subconjunctival space and the anterior chamber. The addition of mitomycin (MMC) is necessary because it is associated with better IOP control and greater surgical success. Although postoperative procedures such as needling or Nd:YAG laser-assisted gonioponctures are often required, SPNP offers good long-term results in patients who are naïve to any filtering surgery.

Minimally invasive surgery has been used more and more over the last 10 years. It aims to reduce surgical complications in comparison to classical filtering procedures while respecting the eye's own anatomy. Several devices have been invented to increase aqueous humor elimination. They can be implanted ab-interno or ab-externo and can be implanted in the suprachoroidal space, in Schlemm's canal or in the subconjunctival space. The XEN gelstent (Allergan, Dublin, Ireland) is placed ab-interno between the subconjunctival space and the anterior chamber, either in combination with cataract surgery or as a solo procedure.

The aim of the study is to compare the surgical success of these 2 techniques. No study has ever compared these 2 surgeries in solo procedure. A recent retrospective trial compared them in combined procedures without showing significant differences in IOP reduction. Nevertheless, the short follow-up period of 9 months may have been insufficient to show a real difference.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient whose age ≥ 18 years
* Patient with primary or secondary open angle glaucoma
* Patient who has undergone a SPNP or XEN procedure in solo
* French speaking patient

Exclusion Criteria

* Angle closure
* Less than 6 months follow-up
* History of eye filtering surgery included
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his/her data for this research

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No