An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses

NCT ID: NCT01004549

Last Updated: 2011-06-28

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-06-30

Brief Summary

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This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.

Detailed Description

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Conditions

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Pseudophakia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bilateral intraocular lens implantation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients age 18 and older
* Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:

* Crystalens
* Crysalens HD
* Tecnis One monofocal
* Patients must have a healthy cornea and macula
* Patients must have 20/25 or better best corrected vision
* Able to provide written informed consent

Exclusion Criteria

* BCVA of less than 20/25
* On oral medications that could potentially block accommodation:

* First generation antihistamines
* Anticholinergic agents
* Anti-psychotic medications
* Antidepressant medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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The Center for Excellence in Eye Care

Principal Investigators

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William Trattler, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Excellence in Eye Care

Locations

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The Center for Excellence in Eye Care

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Accomodation study

Identifier Type: -

Identifier Source: org_study_id

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