Clinical Validation Plan of Capsular Tension Ring

NCT04880018 | Completed DMC

• 2 other identifiers: EB/JS-QD-1232015QXNL002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Best corrected distance visual acuity

  The percentage of eyes whose best corrected distance visual acuity reached 20/40 at 6 months after operation

  At 6 months after operation

Secondary Outcomes (4)

• Best corrected distance visual acuity, uncorrected distance visual acuity

  In 1~2 days, 1 week, 1 month, 3 months, 6 months, 1 year

• Diopter

  In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year

• The intraocular lens eccentricity

  In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year

• The capsular shrinkage

  In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year

Study Arms (2)

Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd

EXPERIMENTAL

Specification model: CTR1109、CTR1210、CTR1311、CTR1412、CTR1513 Manufacturer: Eyebright Medical Technology (Beijing) Co., Ltd.

Device: Capsular Tension Ring

Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd

ACTIVE COMPARATOR

Specification model: TENSIOBAG 10、TENSIOBAG 11、TENSIOBAG 12、TENSIOBAG 13、TENSIOBAG14 Manufacturer: Carl Zeiss Medical Technology Co., Ltd.

Device: Capsular Tension Ring

Interventions

Capsular Tension Ring DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old, no gender limit;
• For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
• Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.

You may not qualify if:

• Over 18 years old, no gender limit;
• For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
• Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.
• The surgical eye has other ocular diseases, those with Capsular Tension Ring implantation or intraocular operation contraindications, such as binocular congenital cataracts, microphthalmia, children under the age of 12 months, corneal dystrophy or endothelial cell insufficiency, chronic uveitis, active ocular diseases (Diabetic retinopathy active stage, uncontrollable glaucoma), fragile capsular bag, zonular rupture exceeding 120 degrees, etc.
• Accompanied by severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental and nerve dysfunction and other diseases;
• The surgical eye has had retinal detachment or retinopathy;
• Patients with congenital cataracts undergoing operation;
• Those whose electrocardiogram examination or laboratory examination results suggest surgical contraindications;
• Those who are unsupervised or cannot follow the doctor's advice;
• Those with a history of intraocular operation in the last 3 months;
• It is estimated that the best corrected distance visual acuity after operation is less than 20/40;
• Those who need combined eye operation;
• Participated in clinical trials of other drugs or medical devices within 30 days before screening;
• Patients who are using or need to use ocular or systemic drugs during the research period that may affect their visual acuity;
• Pregnant or breastfeeding women;

Sponsors & Collaborators

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

Study Officials

• Jian Ye, PhD

  STUDY DIRECTOR

• Yong Zhong, PhD

  STUDY DIRECTOR

• Qi Han, PhD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

• Jun Fang, PhD

  Daqing oilfield general hospital

  STUDY DIRECTOR

• Ayong Yv, PhD

  Opto-optic Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 10, 2021
• Study Start: May 21, 2015
• Primary Completion: June 20, 2017
• Study Completion: October 24, 2017
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share