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Clinical Validation Plan of Capsular Tension Ring

NCT04880018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-05-10

No results posted yet for this study

Summary

Through follow-up for 1 year or more, the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. were verified, which is used for intraocular lens implantation in aphakic eyes after lens extraction to maintain capsular integrity, prevent posterior capsular wrinkle and resist capsular shrinkage.

The clinical validation plan will be implemented after being approved by the Ethics Committee; the trial data of all cases before the 6-month visit period will be counted, and the statistical report, summary report and sub-center summary will be issued. The summary report and sub-center summary will be submitted to the CFDA for product registration.

Conditions

  • Intraocular Lens Implantation

Interventions

DEVICE

Capsular Tension Ring

Experimental group uses Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd;control group uses Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd

Sponsors & Collaborators

  • Eyebright Medical Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jian Ye, PhD

  • Yong Zhong, PhD

  • Qi Han, PhD · Tianjin Medical University General Hospital

  • Jun Fang, PhD · Daqing oilfield general hospital

  • Ayong Yv, PhD · Opto-optic Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-21
Primary Completion
2017-06-20
Completion
2017-10-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880018 on ClinicalTrials.gov