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Comparison of Clinical Outcomes of Toric Intraocular Lens

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ClinicalTrials.gov Identifier: NCT03085901
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
tae-young chung, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Astigmatism Device: Precizon toric intraocular lens Device: Tecnis toric intraocular lens Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Clinical Outcomes of Toric Intraocular Lens
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Active Comparator: Precizon toric intraocular lens
Cataract surgery and implantation of Precizon toric intraocular lens
Device: Precizon toric intraocular lens
Phacoemulsification and implantation of Precizon toric intraocular lens

Active Comparator: Tecnis toric intraocular lens
Cataract surgery and implantation of Tecnis toric intraocular lens
Device: Tecnis toric intraocular lens
Phacoemulsification and implantation of Tecnis toric intraocular lens




Primary Outcome Measures :
  1. Postoperative refractive astigmatism [ Time Frame: postoperative 3 months ]
    Diopter


Secondary Outcome Measures :
  1. Postoperative visual acuity [ Time Frame: postoperative 3 months ]
    logMAR



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: tae-young chung, Professor, Samsung Medical Center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03085901     History of Changes
Other Study ID Numbers: 2016-04-147
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases