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OpenTrials
Completed

NCT Number: NCT03797846

Comparison of Fixation Suture Type in Glaucoma Surgery

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.

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Key information

Conditions

Glaucoma Eye Blepharoptosis Eye Diseases Eyelid Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University

Bialystok, 15-089, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined glaucoma surgery

Procedure

combined procedure with trabeculectomy and cataract removal

Primary outcomes

  1. IOP

    Time frame: baseline and twelve months after surgery

    the change in the level of intraocular pressure

Secondary outcomes

  1. BCVA

    Time frame: baseline and twelve months after surgery

    the change in the best corrected visual acuity

  2. MRD

    Time frame: baseline and twelve months after surgery

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

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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