Comparison of Fixation Suture Type in Glaucoma Surgery

Not Applicable

Completed

• Conditions: Glaucoma; Glaucoma Eye
• Interventions: Procedure: combined glaucoma surgery

• Registration Number: NCT03797846
• Lead Sponsor: Medical University of Bialystok

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-05
• Study First Posted: 2019-01-09
• Study Completion: 2019-06-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-11
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Muscle Suture	combined glaucoma surgery	intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery
Corneal Suture	combined glaucoma surgery	intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery

Primary Outcome Measures

Name	Time	Method
IOP	baseline and twelve months after surgery	the change in the level of intraocular pressure

Secondary Outcome Measures

Name	Time	Method
MRD	baseline and twelve months after surgery	the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm
BCVA	baseline and twelve months after surgery	the change in the best corrected visual acuity

Trial Locations

Locations (1)

Medical University; 🇵🇱 Białystok, Poland