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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03976791
• Other study ID #: 2019KYPJ078
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2019
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yizhi Liu, Doctor
• Phone: 87330475
• Email: liuyizh[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 294
• Est. completion date: December 30, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Surgical Wound

Intervention

Procedure:
• enlarged internal incision
enlarging the internal incision about 0.4mm
• regular 2.2mm incision
2.2mm microincision coaxial phacoemulsification

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	descemet membrane detachment(DMD)	DMD at the incision observed by anterior segment optical coherence tomography	postoperative 1 week