Skip to main content
Clinical Trials/NCT04430647
NCT04430647
Completed
Not Applicable

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

Ameera Gamal Abdelhameed1 site in 1 country61 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Ameera Gamal Abdelhameed
Enrollment
61
Locations
1
Primary Endpoint
reduction in r the number of antiglaucoma medications.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ameera Gamal Abdelhameed
Responsible Party
Sponsor Investigator
Principal Investigator

Ameera Gamal Abdelhameed

Lecturer of Ophthalmology

Mansoura University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • BCVA improvement(18 months postoperative)
  • intraoperative and postoperative complications.(intraoperative and 18 months postoperative)

Study Sites (1)

Loading locations...

Similar Trials