Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Not Applicable

Completed

• Conditions: Ocular Hypertension; Glaucoma; Filtering Surgery
• Interventions: Procedure: phacotrabeculectomy; Procedure: ExPress antiglaucoma surgery combined with phacoemulsification

• Registration Number: NCT04335825
• Lead Sponsor: Medical University of Bialystok

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

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-12-30
• Study First Submitted: 2020-03-28
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Study First Posted: 2020-04-06
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phacotrabeculectomy	phacotrabeculectomy	patients undergoing phacotrabeculectomy
ExPress device implantation	ExPress antiglaucoma surgery combined with phacoemulsification	patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification

Primary Outcome Measures

Name	Time	Method
IOP	baseline and six months after surgery	the change in the level of intraocular pressure

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA)	baseline and six months after surgery	the change in the best corrected visual acuity
astigmatism	baseline and six months after surgery	the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery