Phaco-UCP Versus Phaco Alone for OAG and Cataract

Sponsor

Ameera Gamal Abdelhameed (Other)

Overall Status

Completed

CT.gov ID

NCT04430647

Collaborator

Dar Alshifa hospital Kuwait (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cataract Glaucoma, Open-Angle	Procedure: combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) Procedure: Phacoemulsification alone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

reduction in intraocular pressure [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
reduction in r the number of antiglaucoma medications. [18 months postoperative]
reduction of the number of antiglaucoma medication or at least no increase in the number

Secondary Outcome Measures

BCVA improvement [18 months postoperative]
improvement of best corrected visual acuity
intraoperative and postoperative complications. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura	Dakahlia	Egypt

Sponsors and Collaborators

Ameera Gamal Abdelhameed
Dar Alshifa hospital Kuwait

Investigators

Principal Investigator: Magda Torky, MD, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ameera Gamal Abdelhameed, Lecturer of Ophthalmology, Mansoura University

ClinicalTrials.gov Identifier:

NCT04430647

Other Study ID Numbers:

Phaco-UCP in OAG and cataract

First Posted:

Jun 12, 2020

Last Update Posted:

Jun 12, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Cataract

Glaucoma, Open-Angle

Study Results

No Results Posted as of Jun 12, 2020