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Trial record 1 of 1 for:    NCT04430647
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Phaco-UCP Versus Phaco Alone for OAG and Cataract

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ClinicalTrials.gov Identifier: NCT04430647
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Collaborator:
Dar Alshifa hospital Kuwait
Information provided by (Responsible Party):
Ameera Gamal Abdelhameed, Mansoura University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430647


Locations
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Egypt
Mansoura University
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Ameera Gamal Abdelhameed
Dar Alshifa hospital Kuwait
Investigators
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Principal Investigator: Magda Torky, MD Mansoura University
Publications:
Francis BA, Sarkisian SR, Tan JC (2017). Minimally invasive glaucoma surgery: A practical guide. 1st ed. New York: Thieme.
Bolek, B., Wylegala, A., Mazur, R. and Wylegala, E. (2019), Pupil irregularity after ultrasound ciliary plasty in glaucoma treatment. Acta Ophthalmol, 97:. doi:10.1111/j.1755-3768.2019.5480

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases