Clinical Trials Directory

Trials / Completed

CompletedNCT04335825

Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
81 (actual)
Sponsor
Medical University of Bialystok · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREphacotrabeculectomycombined antiglaucoma procedure: trabeculectomy with phacoemulsification
PROCEDUREExPress antiglaucoma surgery combined with phacoemulsificationcombined antiglaucoma procedure: ExPress device implantation with phacoemulsification

Timeline

Start date
2016-01-01
Primary completion
2019-01-01
Completion
2019-12-30
First posted
2020-04-06
Last updated
2020-04-06

Source: ClinicalTrials.gov record NCT04335825. Inclusion in this directory is not an endorsement.