Comparison of Fixation Suture Type in Glaucoma Surgery

• Sponsor: Medical University of Bialystok (Other)
• Overall Status: Completed
• CT.gov ID: NCT03797846
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Eye; Glaucoma	Procedure: combined glaucoma surgery	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective randomized trial with a 6 month follow-up periodA prospective randomized trial with a 6 month follow-up period
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. IOP [baseline and twelve months after surgery]

   the change in the level of intraocular pressure

Secondary Outcome Measures

1. BCVA [baseline and twelve months after surgery]

   the change in the best corrected visual acuity

2. MRD [baseline and twelve months after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University	Białystok		Poland	15-089

Sponsors and Collaborators

• Medical University of Bialystok

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Joanna Konopińska, MD, PhD, Medical University of Bialystok
• ClinicalTrials.gov Identifier: NCT03797846
• Other Study ID Numbers: 1771
• First Posted: Jan 9, 2019
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joanna Konopińska, MD, PhD, Medical University of Bialystok: ptosis; combined procedures; glaucoma; post-surgery complication
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Jul 14, 2020