Comparison of Fixation Suture Type in Glaucoma Surgery

Medical University of Bialystok

Status: Completed

Conditions: Glaucoma; Glaucoma Eye

Treatments: Procedure: combined glaucoma surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03797846

1771

Details and patient eligibility

About

The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.

This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.

Full description

The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III)
• primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic
• documented progression of loss of field of vision
• significant daily IOP fluctuations
• no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medications

Exclusion criteria

• no consent to participation in the study
• prior surgical and laser procedures in the area of the eye
• narrow- or closed-angle glaucoma
• post-inflammatory or post-traumatic secondary glaucoma
• chronic illness of the cornea or optic nerve
• advanced macular degeneration
• active inflammatory process
• pregnancy
• systemic steroid therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Corneal Suture

Active Comparator group

Description:

intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery

Treatment:

Procedure: combined glaucoma surgery

Muscle Suture

Active Comparator group

Description:

intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery

Treatment:

Procedure: combined glaucoma surgery