Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

NCT ID: NCT04062084

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subluxation of Lens Surgical Instruments,Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multifunctional Cataract-assisted Retractor

Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor

Group Type EXPERIMENTAL

Multifunctional Cataract-assisted Retractor

Intervention Type DEVICE

Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens

Capsule Retractor

Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor

Group Type EXPERIMENTAL

Multifunctional Cataract-assisted Retractor

Intervention Type DEVICE

Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multifunctional Cataract-assisted Retractor

Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of lens subluxation.
* Patients need to undergo lens subluxation surgery

Exclusion Criteria

* Active intraocular inflammation
* The intraocular pressure (IOP) was higher than 25 mmHg
* The endothelial cell count (ECC) was less than 1,200 cells/mm2
* Combined with other eye diseases
* Combined with other serious systemic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

xuwen2017-034

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.