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

Not Applicable

• Conditions: Cataract
• Interventions: Procedure: enlarged internal incision; Procedure: regular 2.2mm incision

• 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

Arm && Interventions

Group	Intervention	Description
Enlarged internal incision	enlarged internal incision	enlarged the internal incision about 0.4mm
Regular 2.2mm incision	regular 2.2mm incision	regular 2.2mm corneal incision for microincision coaxial phacoemulsification

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