Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract

Cataract Extraction Clinical Trial

Official title:

Comparison of Intraocular Caliper-assisted and Verion Navigation System-assisted Capsulotomy in Phacoemulsification Surgery: A Randomized Non-inferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04977115
• Other study ID #: 2021KYPJ110
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2021
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Xiaoyun Chen, PhD
• Phone: +86 13632343642
• Email: chenxiaoyun[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 of patients.

Description:

Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. However, most surgeons perform CCC by experience or referring to the pupil size, which is highly subjective and the accuracy of capsulorhexis is unsatisfactory. The investigators developed a new modified intraocular caliper with standard calibration on the rinse needle, which can measure and locate the position of capsulorhexis. The surgeon can gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. We found intraocular caliper-assisted capsulotomy can obviously improve the accuracy of capsulorhexis. The purpose of this study is to compare the accuracy and postoperative visual quality of intraocular caliper-assisted capsulotomy with those of digital image projection device VERION navigation system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: April 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults aged 55 to 80 years with age-related cataract;
• Pupil diameter = 6.5mm after pupil dilation;
• Lens nuclear opacity grading score (LOCS III) lower than 4.0.

Exclusion Criteria:

• Patients had previous intraocular surgery;
• Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
• Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
• Refused to participate the study.

Related Conditions & MeSH terms

• Cataract
• Cataract Extraction

Intervention

Procedure:
• Intraocular caliper-assisted capsulotomy
Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
• 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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center,Sun Yat-Sen University	Guangzhou

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	Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)	Images of the edges of IOL and capsulorhexis are taken at the end of the operation. Image J image analysis software is used to measure the horizontal diameter and vertical diameter of capsulorhexis with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime, and further calculate the deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm) .	During the surgery
Secondary	Uncorrected and corrected visual acuity	Visual acuity is evaluated with ETDRS visual acuity chart.	One month after surgery
Secondary	Ideal ratio of capsulorhexis	Ideal capsulorhexis is defined as a centered and round capsulorhexis, which can cover the edge of IOL optical surface continuously for 360 degrees with a diameter between 5.0 to 5.5 mm.	During the surgery
Secondary	Grades of capsulorhexis-IOL overlap	The capsulorhexis-IOL overlap of each patient is graded as 360-degree continuous overlap, 270~360-degree overlap, 180~270-degree overlap, 90~180-degree overlap, and < 90-degree overlap.	During the surgery
Secondary	Distance between pupil center and capsulorhexis center	Measured by Image J image analysis software.	During the surgery
Secondary	Horizontal and vertical diameter of capsulorhexis	Measured by Image J image analysis software.	During the surgery
Secondary	Intraocular lens tilt	Measured by anterior segment OCT (CASIA2).	One month after surgery
Secondary	Intraocular lens decentration	Measured by anterior segment OCT (CASIA2).	One month after surgery
Secondary	Intraocular aberrations	Measured by OPD-SCAN III.	One month after surgery
Secondary	Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)		One month after surgery