NCT04014699

Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.

Detailed description

2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery. The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore，the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications. In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.

Conditions

• Cataract

Interventions

Type	Name	Description
PROCEDURE	modified 2.2mm microincision	enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification
PROCEDURE	conventional 2.2mm microincision	conventional 2.2mm coaxial microincision phacoemulsification

Timeline

• Start date: 2019-07-22
• Primary completion: 2019-10-22
• Completion: 2020-01-22
• First posted: 2019-07-10
• Last updated: 2020-09-16

Locations

1 site across 1 country: China