Surgical and Refractive Outcomes of Combined Glaucoma Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Filtering Surgery
• Intervention / Treatment: Procedure: phacotrabeculectomy; Procedure: ExPress antiglaucoma surgery combined with phacoemulsification

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	the change in the level of intraocular pressure	baseline and six months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Bialystok

Publications and helpful links

General Publications

• Chan HHL, Kong YXG. Glaucoma surgery and induced astigmatism: a systematic review. Eye Vis (Lond). 2017 Nov 17;4:27. doi: 10.1186/s40662-017-0090-x. eCollection 2017.
• Hong YJ, Choe CM, Lee YG, Chung HS, Kim HK. The effect of mitomycin-C on postoperative corneal astigmatism in trabeculectomy and a triple procedure. Ophthalmic Surg Lasers. 1998 Jun;29(6):484-9.
• Alvani A, Pakravan M, Esfandiari H, Safi S, Yaseri M, Pakravan P. Ocular Biometric Changes after Trabeculectomy. J Ophthalmic Vis Res. 2016 Jul-Sep;11(3):296-303. doi: 10.4103/2008-322X.188399.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (ACTUAL): April 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: glaucoma combined surgery; postoperative astigmatism; postsurgery refractive error
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 1774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data of each participant will be available upon email request for all primary and secondary outcome measures
• IPD Sharing Time Frame: Data will be available on email request for six months after completing the study
• IPD Sharing Access Criteria: e mail request, after Data Access Agreement is sign
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No