Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Sponsor
Medical University of Bialystok (Other)
Overall Status
Completed
CT.gov ID
NCT04335825
Collaborator
(none)
81
2
47.9

Study Details

Study Description

Brief Summary

The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up

Condition or Disease Intervention/Treatment Phase
  • Procedure: phacotrabeculectomy
  • Procedure: ExPress antiglaucoma surgery combined with phacoemulsification
N/A

Detailed Description

Trabeculectomy and implantation of the Ex-Press device belong to the same group of anti-glaucoma procedures improving subconjunctival outflow. The most frequently performed glaucoma surgery of choice is still trabeculectomy, although the less invasive implantation of the Ex-Press device is also an effective alternative. Despite the wide application of these two techniques, their impact on postoperative refraction is not entirely known. Quite often, in the early postoperative period there is a decrease in visual function, which is short-term, although there are reports that it can last up to a year after surgery. It can be caused by a reduction in IOP, as well as the direct effect of trabeculectomy on corneal topography, and thus on postoperative astigmatism and refractive error. The occurrence of astigmatism after trabeculectomy has been widely documented Combined operations of implanting the ExPress implant with cataract phacoemulsification differ from phacotrabeculectomy in that, they do not require cutting of the sclera, cutting the limbus and using a punch.

The purpose of our research was to compare the phacotrabeculectomy and phacoemulsification combined with Express device implantation in terms of incidence of postoperative astigmatism in a prospective randomized study, and to attempt to determine what factors determine its size.

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: phacotrabeculectomy

patients undergoing phacotrabeculectomy

Procedure: phacotrabeculectomy
combined antiglaucoma procedure: trabeculectomy with phacoemulsification

Active Comparator: ExPress device implantation

patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification

Procedure: ExPress antiglaucoma surgery combined with phacoemulsification
combined antiglaucoma procedure: ExPress device implantation with phacoemulsification

Outcome Measures

Primary Outcome Measures

  1. IOP [baseline and six months after surgery]

    the change in the level of intraocular pressure

Secondary Outcome Measures

  1. Best corrected visual acuity (BCVA) [baseline and six months after surgery]

    the change in the best corrected visual acuity

  2. astigmatism [baseline and six months after surgery]

    the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery.

  • Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP >21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment.

  • Additional inclusion criteria were as follows: well documented progression of visual field defects, significant diurnal variations in the IOP, poor patient compliance, and allergy to topical drugs.

Exclusion Criteria:
  • Lack of consent to participate in the study,

  • History of eye surgery or laser procedures within the eye,

  • Closed or narrow angle glaucoma,

  • Diabetes,

  • Advanced macular degeneration

  • Active inflammatory disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Bialystok

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Bialystok
ClinicalTrials.gov Identifier:
NCT04335825
Other Study ID Numbers:
  • 1774
First Posted:
Apr 6, 2020
Last Update Posted:
Apr 6, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medical University of Bialystok
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2020