Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Medical University of Bialystok

Status: Completed

Conditions: Glaucoma; Ocular Hypertension; Filtering Surgery

Treatments: Procedure: phacotrabeculectomy; Procedure: ExPress antiglaucoma surgery combined with phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT04335825

1774

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

phacotrabeculectomy

Active Comparator group

Description:

patients undergoing phacotrabeculectomy

Treatment:

Procedure: phacotrabeculectomy

ExPress device implantation

Active Comparator group

Description:

patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification

Treatment:

Procedure: ExPress antiglaucoma surgery combined with phacoemulsification