Visual Quality Following Aspheric Intraocular Lens (IOL)... | NCT01544777

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

NCT01544777

Sponsor

Hoya Surgical Optics, Inc.

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Aphakia
Cataract

Interventions

Study IOL
Hoya iSert 751
Negatively aspheric IOL

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Feb 21, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Both Eyes	Experimental	Model 751 IOL implanted in both eyes.	Device: Study IOL
Single eye	Experimental	Model 751 IOL in one eye	Device: Hoya iSert 751
Control	Active Comparator	Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent	Device: Negatively aspheric IOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study IOL	Device	Aspheric IOL for correction of aphakia	Both Eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near		Up to 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Graham Barrett, MD	Sir Charles Gairdner Hospital, Nedlans WA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Charles Gairdner Hospital		Nedlands	Western Australia	6009	Australia

Condition Browse Module

MeSH Terms

ID	Term
D001035	Aphakia
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided