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

Sun Yat-sen University

Status: Unknown

Conditions: Cataract Extraction

Treatments: Procedure: Verion navigation system-assisted capsulotomy; Procedure: Intraocular caliper-assisted capsulotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04977115

2021KYPJ110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Intraocular caliper-assisted capsulotomy group

Experimental group

Description:

In intraocular caliper-assisted capsulotomy group, a modified intraocular caliper with standard calibration on the rinse needle was used to measure and locate the position of capsulorhexis with 5.3 mm diameter and the principle of pupillary margin in concentric circles. The surgeon could 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.

Treatment:

Procedure: Intraocular caliper-assisted capsulotomy

Verion navigation system-assisted capsulotomy group

Active Comparator group

Description:

In the Verion-assisted capsulotomy group, Verion navigation system was applied to project a 5.3 mm capsulorhexis centered on the corneal vertex. According to the projected capsulorhexis, capsulotomy was performed.

Treatment:

Procedure: Verion navigation system-assisted capsulotomy