Comparison of Fixation Suture Type in Glaucoma Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures

Conditions
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Glaucoma Eye, Glaucoma

Intervention / Treatment
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* Procedure: combined glaucoma surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized trial with a 6 month follow-up period
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corneal Suture<br>intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery | Procedure: combined glaucoma surgery<br>* combined procedure with trabeculectomy and cataract removal<br>|
| Active Comparator: Muscle Suture<br>intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery | Procedure: combined glaucoma surgery<br>* combined procedure with trabeculectomy and cataract removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP | the change in the level of intraocular pressure | baseline and twelve months after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ptosis, combined procedures, glaucoma, post-surgery complication