NCT04977102

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 for age-related cataract patients with corneal limbus opacity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 16, 2021

Last Update Submit

July 20, 2021

Conditions

Cataract Extraction

Outcome Measures

Primary Outcomes (1)

  • Distance between pupil center and capsulorhexis center

    The primary outcome was the distance between pupil center and capsulorhexis center. Clear images of the edges of IOL and capsulorhexis were taken at the end of the operation, and Image J image analysis software is used to measure the distance between pupil center and capsulorhexis center with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime.

    During the surgery

Secondary Outcomes (9)

  • Uncorrected and corrected visual acuity

    One month after surgery

  • Ideal ratio of capsulorhexis

    During the surgery

  • Grades of capsulorhexis-IOL overlap

    During the surgery

  • Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)

    During the surgery

  • Horizontal and vertical diameter of capsulorhexis

    During the surgery

  • +4 more secondary outcomes

Study Arms (2)

Intraocular caliper-assisted capsulotomy group

EXPERIMENTAL

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.

Procedure: Intraocular caliper-assisted capsulotomy

Verion navigation system-assisted capsulotomy group

ACTIVE COMPARATOR

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.

Procedure: Verion navigation system-assisted capsulotomy

Interventions

Intraocular caliper-assisted capsulotomyPROCEDURE

Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.

Intraocular caliper-assisted capsulotomy group
Verion navigation system-assisted capsulotomyPROCEDURE

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.

Verion navigation system-assisted capsulotomy group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 55 to 80 years with age-related cataract with pterygium, Corneal geriatric ring, and corneal limbus opacity;
  • Pupil diameter ≥ 6.5mm after pupil dilation;
  • Lens nuclear opacity grading score (LOCS III) lower than 4.0.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

Location

Central Study Contacts

Xiaoyun Chen, PhD

CONTACT

+86 13632343642chenxiaoyun@gzzoc.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 26, 2021

Study Start

August 1, 2021

Primary Completion

July 31, 2022

Study Completion

October 31, 2022

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

CN(1)