A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

NCT ID: NCT03976791

Last Updated: 2019-06-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-12-30

Brief Summary

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Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Enlarged internal incision

enlarged the internal incision about 0.4mm

Group Type EXPERIMENTAL

enlarged internal incision

Intervention Type PROCEDURE

enlarging the internal incision about 0.4mm

Regular 2.2mm incision

regular 2.2mm corneal incision for microincision coaxial phacoemulsification

Group Type PLACEBO_COMPARATOR

regular 2.2mm incision

Intervention Type PROCEDURE

2.2mm microincision coaxial phacoemulsification

Interventions

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enlarged internal incision

enlarging the internal incision about 0.4mm

Intervention Type PROCEDURE

regular 2.2mm incision

2.2mm microincision coaxial phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age-related cataract patients
* Age from 65 to 90
* The diameter of pupil after mydriasis is more than 6 mm
* LOCS III nuclear grade ≥4
* Corneal endothelial cell count \> 1500 cells/mm2
* Phacoemulsification and intraocular lens implantation are planned
* Agree to participate in this study and sign informed consent

Exclusion Criteria

* History of ocular trauma
* Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
* Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
* History of Ophthalmic Surgery
* Intraoperative and Postoperative Complications
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yizhi Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yizhi Liu, Doctor

Role: CONTACT

Facility Contacts

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Yizhi Liu, Doctor

Role: primary

Other Identifiers

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2019KYPJ078

Identifier Type: -

Identifier Source: org_study_id

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