Phaco-UCP Versus Phaco Alone for OAG and Cataract

NCT04430647 | Completed

• 1 other identifier: Phaco-UCP in OAG and cataract
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Cataract; Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

• reduction in intraocular pressure

  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.

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

  18 months postoperative

Secondary Outcomes (2)

• BCVA improvement

  18 months postoperative

• intraoperative and postoperative complications.

  intraoperative and 18 months postoperative

Study Arms (2)

phaco-UCP

EXPERIMENTAL

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)

Phaco alone

ACTIVE COMPARATOR

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

Interventions

combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) PROCEDURE

performing ultrasound ciliary plasty then performing standard phacoemulsification

phaco-UCP

Phacoemulsification alone PROCEDURE

standard phacoemulsification for catarct extraction

Phaco alone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ameera Gamal Abdelhameed: lead
• Dar Alshifa hospital Kuwait: collaborator

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

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  PMID: 33478426 DERIVED

MeSH Terms

Conditions

Cataract; Glaucoma, Open-Angle

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Glaucoma; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Magda Torky, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: March 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: January 30, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

EG (1)