Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study

NCT ID: NCT01544777

Last Updated: 2015-03-25

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

Detailed Description

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Conditions

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Aphakia Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Both Eyes

Model 751 IOL implanted in both eyes.

Group Type EXPERIMENTAL

Study IOL

Intervention Type DEVICE

Aspheric IOL for correction of aphakia

Single eye

Model 751 IOL in one eye

Group Type EXPERIMENTAL

Hoya iSert 751

Intervention Type DEVICE

Model 751 in one eye, standard IOL in other eye

Control

Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

Group Type ACTIVE_COMPARATOR

Negatively aspheric IOL

Intervention Type DEVICE

Negatively aspheric IOL in both eyes

Interventions

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Study IOL

Aspheric IOL for correction of aphakia

Intervention Type DEVICE

Hoya iSert 751

Model 751 in one eye, standard IOL in other eye

Intervention Type DEVICE

Negatively aspheric IOL

Negatively aspheric IOL in both eyes

Intervention Type DEVICE

Other Intervention Names

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Hoya iSert 751 IOL Hoya iSert Model 751 Hoya iSert model 251 or equivalent

Eligibility Criteria

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Inclusion Criteria

* Senile cataract
* Patient identified as a candidate for cataract surgery and IOL implantation
* Willing to sign informed consent document approved by the Ethical Committee
* Willing to complete all required tests and exams per this protocol

Exclusion Criteria

* Amblyopia
* History or evidence of any ocular disease that may affect visual acuity
* Previous ocular surgery, including refraction surgery
* Ocular anomalies (e.g. microphthalmos, kerataconous)
* Subjects with greater than 1.0 D of corneal astigmatism
* Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoya Surgical Optics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graham Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

Sir Charles Gairdner Hospital, Nedlans WA

Locations

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Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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DOF-1

Identifier Type: -

Identifier Source: org_study_id

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