Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

NCT ID: NCT05530473

Last Updated: 2023-04-28

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-03-30

Brief Summary

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This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.

Detailed Description

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Conditions

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Intraocular Lens Rotation Capsular Tension Ring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CTR Group

Eyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery.

Group Type EXPERIMENTAL

capsular tension ring

Intervention Type DEVICE

To insert a capsular tension ring during the cataract surgery

NCTR Group

Eyes underwent cataract surgery without implanting a CTR.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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capsular tension ring

To insert a capsular tension ring during the cataract surgery

Intervention Type DEVICE

Other Intervention Names

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capsular tension ring (ACPi-11; Bausch&Lomb)

Eligibility Criteria

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Inclusion Criteria

-cataract

Exclusion Criteria

* preexisting corneal pathology
* small pupil
* glaucoma
* zonular dehiscence
* a history of ocular trauma or surgery
* uveitis
* intraoperative complications
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Jin Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital

Locations

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Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Lin X, Ma D, Han X, Hua Z, Shen W, Qiu X, Cai L, Yang J. Rotational stability of plate-haptic toric intraocular lenses implantation with a capsular tension ring: prospective randomized paired-eye study. J Cataract Refract Surg. 2025 Jan 1;51(1):31-39. doi: 10.1097/j.jcrs.0000000000001554.

Reference Type DERIVED
PMID: 39353092 (View on PubMed)

Other Identifiers

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IOL&CTR

Identifier Type: -

Identifier Source: org_study_id

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