NCT03797846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

January 3, 2019

Last Update Submit

July 11, 2020

Conditions

Glaucoma EyeGlaucoma

Keywords

ptosiscombined proceduresglaucomapost-surgery complication

Outcome Measures

Primary Outcomes (1)

  • IOP

    the change in the level of intraocular pressure

    baseline and twelve months after surgery

Secondary Outcomes (2)

  • BCVA

    baseline and twelve months after surgery

  • MRD

    baseline and twelve months after surgery

Study Arms (2)

Corneal Suture

ACTIVE COMPARATOR

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

Procedure: combined glaucoma surgery

Muscle Suture

ACTIVE COMPARATOR

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

Procedure: combined glaucoma surgery

Interventions

combined glaucoma surgeryPROCEDURE

combined procedure with trabeculectomy and cataract removal

Corneal SutureMuscle Suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Bialystok, 15-089, Poland

Location

Related 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.

    PMID: 25803293BACKGROUND

MeSH Terms

Conditions

GlaucomaBlepharoptosis

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesEyelid Diseases

Study Officials

  • Zofia Mariak, Prof

    Medical University of Bialystok

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective randomized trial with a 6 month follow-up period
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 9, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

De-identified data of each participant will be available on email request for all primary and secondary outcome measures

Shared Documents
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

Locations

PL(1)