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Completed

NCT Number: NCT04335825

Surgical and Refractive Outcomes of Combined Glaucoma Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phacotrabeculectomy

Procedure

combined antiglaucoma procedure: trabeculectomy with phacoemulsification

ExPress antiglaucoma surgery combined with phacoemulsification

Procedure

combined antiglaucoma procedure: ExPress device implantation with phacoemulsification

Primary outcomes

  1. IOP

    Time frame: baseline and six months after surgery

    the change in the level of intraocular pressure

Secondary outcomes

  1. Best corrected visual acuity (BCVA)

    Time frame: baseline and six months after surgery

    the change in the best corrected visual acuity

  2. astigmatism

    Time frame: baseline and six months after surgery

    the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2020
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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