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Comparison of Fixation Suture Type in Glaucoma Surgery

Primary Purpose

Glaucoma Eye, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
combined glaucoma surgery
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Eye focused on measuring ptosis, combined procedures, glaucoma, post-surgery complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Corneal Suture

Muscle Suture

Arm Description

intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery

intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery

Outcomes

Primary Outcome Measures

IOP
the change in the level of intraocular pressure

Secondary Outcome Measures

BCVA
the change in the best corrected visual acuity
MRD
the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm

Full Information

First Posted
January 3, 2019
Last Updated
July 11, 2020
Sponsor
Medical University of Bialystok
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1. Study Identification

Unique Protocol Identification Number
NCT03797846
Brief Title
Comparison of Fixation Suture Type in Glaucoma Surgery
Official Title
Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Bialystok

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Eye, Glaucoma
Keywords
ptosis, combined procedures, glaucoma, post-surgery complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized trial with a 6 month follow-up period
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corneal Suture
Arm Type
Active Comparator
Arm Description
intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery
Arm Title
Muscle Suture
Arm Type
Active Comparator
Arm Description
intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery
Intervention Type
Procedure
Intervention Name(s)
combined glaucoma surgery
Intervention Description
combined procedure with trabeculectomy and cataract removal
Primary Outcome Measure Information:
Title
IOP
Description
the change in the level of intraocular pressure
Time Frame
baseline and twelve months after surgery
Secondary Outcome Measure Information:
Title
BCVA
Description
the change in the best corrected visual acuity
Time Frame
baseline and twelve months after surgery
Title
MRD
Description
the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm
Time Frame
baseline and twelve months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zofia Mariak, Prof
Organizational Affiliation
Medical University of Bialystok
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University
City
Białystok
ZIP/Postal Code
15-089
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
25803293
Citation
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.
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Comparison of Fixation Suture Type in Glaucoma Surgery

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