Comparison of Clinical Outcomes of Toric Intraocular Lens

NCT ID: NCT03085901

Last Updated: 2017-03-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

Detailed Description

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In cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. When patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

Conditions

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Astigmatism

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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Precizon toric intraocular lens

Cataract surgery and implantation of Precizon toric intraocular lens

Group Type ACTIVE_COMPARATOR

Precizon toric intraocular lens

Intervention Type DEVICE

Phacoemulsification and implantation of Precizon toric intraocular lens

Tecnis toric intraocular lens

Cataract surgery and implantation of Tecnis toric intraocular lens

Group Type ACTIVE_COMPARATOR

Tecnis toric intraocular lens

Intervention Type DEVICE

Phacoemulsification and implantation of Tecnis toric intraocular lens

Interventions

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Precizon toric intraocular lens

Phacoemulsification and implantation of Precizon toric intraocular lens

Intervention Type DEVICE

Tecnis toric intraocular lens

Phacoemulsification and implantation of Tecnis toric intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

Exclusion Criteria

* Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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tae-young chung

Professor, Samsung Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.

Reference Type DERIVED
PMID: 30413154 (View on PubMed)

Other Identifiers

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2016-04-147

Identifier Type: -

Identifier Source: org_study_id

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