A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Not Applicable

• Conditions: Cataract

• Registration Number: NCT03976791
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-14
• Study Start: 2019-07-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Age-related cataract patients
• Age from 65 to 90
• The diameter of pupil after mydriasis is more than 6 mm
• LOCS III nuclear grade ≥4
• Corneal endothelial cell count > 1500 cells/mm2
• Phacoemulsification and intraocular lens implantation are planned
• Agree to participate in this study and sign informed consent

Exclusion Criteria

• History of ocular trauma
• Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
• Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
• History of Ophthalmic Surgery
• Intraoperative and Postoperative Complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
descemet membrane detachment(DMD)	postoperative 1 week	DMD at the incision observed by anterior segment optical coherence tomography

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China