Clinical trial NCT04977115: Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract
Official title: Comparison of Intraocular Caliper-assisted and Verion Navigation System-assisted Capsulotomy in Phacoemulsification Surgery: A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract Extraction
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 156
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
timeFrame: During the surgery
Secondary outcomes:
measure: Uncorrected and corrected visual acuity
timeFrame: One month after surgery
measure: Ideal ratio of capsulorhexis
timeFrame: During the surgery
measure: Grades of capsulorhexis-IOL overlap
timeFrame: During the surgery
measure: Distance between pupil center and capsulorhexis center
timeFrame: During the surgery
measure: Horizontal and vertical diameter of capsulorhexis
timeFrame: During the surgery
measure: Intraocular lens tilt
timeFrame: One month after surgery
measure: Intraocular lens decentration
timeFrame: One month after surgery
measure: Intraocular aberrations
timeFrame: One month after surgery
measure: Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center，Sun Yat-Sen University
Study officials:
References: