NCT04977102

A Randomized Study of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract Patients With Corneal Limbus Opacity

A Randomized Controlled Trial Comparing Intraocular Caliper-assisted Capsulotomy Versus Verion Navigation System-assisted Capsulotomy for Age-related Cataract With Corneal Limbus Opacity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity.

Detailed description

Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. Too large or too small capsulorhexis can increase the incidence of intraoperative and postoperative complications. In recent years, the image projection device Verion navigation system has been reported that it can improve the repeatability and accuracy of capsulorhexis via projecting a pre-set size ring to guide capsulorhexis. However, we found that for the patients with corneal geriatric ring, pterygium or limbal lesions leading to unclear limbal boundary, the projected capsulorhexis will deviate from the center, resulting in capsulorhexis is off center in clinical practice. Our self-developed intraocular caliper, which is modified on the conventional intraocular irrigation needle, can accurately measure the size of capsulorhexis, and mark the position and boundary of capsulorhexis on the lens anterior capsule to guide capsulorhexis, thus significantly improves the accuracy and centricity of capsulorhexis. The purpose of this study is to compare the centricity and accuracy of intraocular caliper-assisted capsulorhexis in phacoemulsification for age-related cataract patients with corneal limbus opacity with that of Verion projection navigation system.

Conditions

• Cataract Extraction

Interventions

Type	Name	Description
PROCEDURE	Intraocular caliper-assisted capsulotomy	Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
PROCEDURE	Verion navigation system-assisted capsulotomy	Verion Image Guided System (Alcon Laboratories, Inc.) is a digital image guidance system consisting of a diagnostic reference unit and a surgery pilot for intraoperative surgical assistance. The device can be used to align toric intraocular lens during surgery as well as support manual creation of a capsulorhexis with a predefined target diameter.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-07-31
• Completion: 2022-10-31
• First posted: 2021-07-26
• Last updated: 2021-07-26

Locations

1 site across 1 country: China