Phaco-UCP Versus Phaco Alone for OAG and Cataract

June 11, 2020 updated by: Ameera Gamal Abdelhameed

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: phaco-UCP
Under peribulbar anesthesia, UCP was performed first, followed by phacoemulsification. UCP was performed using the same technique described before [18]. For all treatments, 2nd generation probe was used (EyeOP1, Eye Tech care; France) with the same parameters; Operating frequency was 21 MHz. Number of sectors activated was 6. Acoustic power was 2.45 W; duration of each shot was 8s; and the time between shots was 20s. The probe diameter (11, 12 or 13 mm) was determined according to the eye's biometric readings. The coupling cone was centered on the eye and kept in place with low vacuum suction, followed by introduction of the treatment probe inside the cone, then activation of the transducers by constantly pressing the foot switch. Once UCP treatment was finished, phacoemulsification was commenced
Procedure: combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)
performing ultrasound ciliary plasty then performing standard phacoemulsification
Active Comparator: Phaco alone
A standard phacoemulsification was performed with 2.2 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification and intrabagal implantation of foldable acrylic intraocular lens (AcrySof® IQ SN60WF monofocal; Alcon Laboratories Inc, Fort Worth, TX, USA) for all patients. Irrigation-aspiration was performed for at least 30 seconds to remove any viscoelastic from the anterior chamber. Reformation of the anterior chamber was done with balanced saline solution (BSS), followed by hydration of the corneal wound and side port.
Procedure: Phacoemulsification alone
standard phacoemulsification for catarct extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months postoperative
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
18 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA improvement
Time Frame: 18 months postoperative
improvement of best corrected visual acuity
18 months postoperative
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.
intraoperative and 18 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ameera Gamal Abdelhameed

Collaborators

Dar Alshifa hospital Kuwait

Investigators

  • Principal Investigator: Magda Torky, MD, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phaco-UCP in OAG and cataract

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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