Comparison of Fixation Suture Type in Glaucoma Surgery

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797846
• Other study ID #: 1771
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2020
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye

Intervention

Procedure:
• combined glaucoma surgery
combined procedure with trabeculectomy and cataract removal

Locations

Country	Name	City	State
Poland	Medical University	Bialystok

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP	the change in the level of intraocular pressure	baseline and twelve months after surgery
Secondary	BCVA	the change in the best corrected visual acuity	baseline and twelve months after surgery
Secondary	MRD	the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) =2mm	baseline and twelve months after surgery