Skip to main content
OpenTrials
Completed

NCT Number: NCT04430647

Phaco-UCP Versus Phaco Alone for OAG and Cataract

This study was carried out to evaluate the safety and efficacy of combined phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical treatment of coexisting cataract and op

/en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first report of results of combined Phaco-UCP

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Glaucoma Glaucoma, Open-Angle Lens Diseases Ocular Hypertension

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma, 31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed with phacoemulsification alone.

Patients were randomized for either combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All surgeries were performed by one experienced surgeon (Y EZ).

Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany). Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were also performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification

Exclusion criteria

  • patients with any other type of glaucoma, including narrow angle glaucoma, neovascular, uveitic or angle recession glaucoma, patients with advanced glaucoma characterized by advanced optic disc cupping or visual field damage, history of glaucoma or intraocular surgery and other ocular diseases that would affect safety or interfere with the procedure. We also excluded patients with incomplete follow-up or missing data

Treatment and study plan

combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)

Procedure

performing ultrasound ciliary plasty then performing standard phacoemulsification

phacoemulsification alone

Procedure

standard phacoemulsification for catarct extraction

Primary outcomes

  1. reduction in intraocular pressure

    Time frame: 18 months postoperative

    Qualified Success was defined as an IOP reduction of at least 20 % from baseline value, with an IOP that is between 6 - 21 mm Hg, without the need for additional antiglaucoma medications or glaucoma surgery

  2. reduction in r the number of antiglaucoma medications.

    Time frame: 18 months postoperative

    reduction of the number of antiglaucoma medication or at least no increase in the number

Secondary outcomes

  1. BCVA improvement

    Time frame: 18 months postoperative

    improvement of best corrected visual acuity

  2. intraoperative and postoperative complications.

    Time frame: intraoperative and 18 months postoperative

    hyphema or vitreous hemorrhage necessitating surgical intervention, choroidal hemorrhage, chronic uveitis, endophthalmitis, hypotony (IOP ≤ 5 mm Hg), phthisis, IOL dislocation, and retinal detachment.

Sponsors and collaborators

Lead sponsor

Ameera Gamal Abdelhameed

Other

Collaborators

  • Dar Alshifa hospital Kuwait

Registry information

Official study title

Phaco-UCP; Combined Phacoemulsification and Ultrasound Ciliary Plasty Versus Phacoemulsification Alone for Management of Coexisting Cataract and Open Angle Glaucoma

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 12, 2020
Registry last updated
Jun 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.