Comparison of Fixation Suture Type in Glaucoma Surgery

Medical University of Bialystok41 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Eye Glaucoma

Interventions

combined glaucoma surgeryPROCEDURE

combined procedure with trabeculectomy and cataract removal

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University

Bialystok, Poland

Outcomes

Primary Outcomes

IOP

the change in the level of intraocular pressure

Time frame: baseline and twelve months after surgery

Secondary Outcomes

BCVA

the change in the best corrected visual acuity

Time frame: baseline and twelve months after surgery

MRD

the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm

Time frame: baseline and twelve months after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.