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Comparison of Fixation Suture Type in Glaucoma Surgery

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ClinicalTrials.gov Identifier: NCT03797846
Recruitment Status : Completed
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Joanna Konopińska, Medical University of Bialystok

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 procedures (phacotrabeculectomy and phacoemulsification combined with implantation of ExPress device). 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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 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 : January 1, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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/ ExPress device implantation with simultaneous 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/ ExPress device implantation with simultaneous cataract removal




Primary Outcome Measures :
  1. IOP [ Time Frame: baseline and six months after surgery ]
    the change in the level of intraocular pressure


Secondary Outcome Measures :
  1. BCVA [ Time Frame: baseline and six months after surgery ]
    the change in the best corrected visual acuity

  2. MRD [ Time Frame: baseline and six months after surgery ]
    the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797846


Locations
Poland
Medical University
Białystok, Poland, 15-089
Sponsors and Collaborators
Medical University of Bialystok
Investigators
Study Chair: Zofia Mariak, Prof Medical University of Bialystok

Publications:
Responsible Party: Joanna Konopińska, MD, PhD, Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03797846     History of Changes
Other Study ID Numbers: 1771
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data of each participant will be available on email request for all primary and secondary outcome measures
Supporting Materials: Study Protocol
Time Frame: Data will be available on email request for six months after completing recruitment
Access Criteria: e-mail request, after Data Access Agreement is sign

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanna Konopińska, Medical University of Bialystok:
ptosis
combined procedures
glaucoma
post-surgery complication

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases