Comparison of Fixation Suture Type in Glaucoma Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Glaucoma Eye
• Intervention / Treatment: Procedure: combined glaucoma surgery

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Investigators: Study Chair: Zofia Mariak, Prof, Medical University of Bialystok

Publications and helpful links

General Publications

• Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 5, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 11, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: glaucoma; ptosis; combined procedures; post-surgery complication
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 1771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data of each participant will be available on email request for all primary and secondary outcome measures
• IPD Sharing Time Frame: Data will be available on email request for six months after completing recruitment
• IPD Sharing Access Criteria: e-mail request, after Data Access Agreement is sign
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No