Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-12-30

Brief Summary

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

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Detailed Description

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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

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Glaucoma Ocular Hypertension Filtering Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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phacotrabeculectomy

patients undergoing phacotrabeculectomy

Group Type ACTIVE_COMPARATOR

phacotrabeculectomy

Intervention Type PROCEDURE

combined antiglaucoma procedure: trabeculectomy with phacoemulsification

ExPress device implantation

patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification

Group Type ACTIVE_COMPARATOR

ExPress antiglaucoma surgery combined with phacoemulsification

Intervention Type PROCEDURE

combined antiglaucoma procedure: ExPress device implantation with phacoemulsification

Interventions

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phacotrabeculectomy

combined antiglaucoma procedure: trabeculectomy with phacoemulsification

Intervention Type PROCEDURE

ExPress antiglaucoma surgery combined with phacoemulsification

combined antiglaucoma procedure: ExPress device implantation with phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No