Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract
NCT ID: NCT04977115
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
156 participants
INTERVENTIONAL
2021-07-26
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Intraocular caliper-assisted capsulotomy group
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.
Intraocular caliper-assisted capsulotomy
Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
Verion navigation system-assisted capsulotomy group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Pupil diameter ≥ 6.5mm after pupil dilation;
* Lens nuclear opacity grading score (LOCS III) lower than 4.0.
Exclusion Criteria
* 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.
55 Years
80 Years
ALL
No
Sponsors
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Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Locations
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Zhongshan Ophthalmic Center，Sun Yat-Sen University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021KYPJ110
Identifier Type: -
Identifier Source: org_study_id
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