Phaco-UCP Versus Phaco Alone for OAG and Cataract

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430647
• Other study ID #: Phaco-UCP in OAG and cataract
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: June 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 30, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle

Intervention

Procedure:
• combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)
performing ultrasound ciliary plasty then performing standard phacoemulsification
• Phacoemulsification alone
standard phacoemulsification for catarct extraction

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (2)

Lead Sponsor	Collaborator
Ameera Gamal Abdelhameed	Dar Alshifa hospital Kuwait

Country where clinical trial is conducted

Egypt, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	BCVA improvement	improvement of best corrected visual acuity	18 months postoperative
Secondary	intraoperative and postoperative complications.	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