Evaluation of Glistenings in Intraocular Lenses Implanted... | NCT01131481

Studies
Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction.

NCT01131481

Sponsor

Fry Eye Associates and Fry Eye Surgery Center

Status

Withdrawn

Last Update Posted

Sep 15, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Glistenings

Interventions

Intraocular lens

Countries

United States

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2013Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

May 26, 2010

First Submission Date that Met QC Criteria

May 26, 2010

First Posted Date

May 27, 2010Estimated

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

Sep 14, 2015

Last Update Posted Date

Sep 15, 2015Estimated

Name	Class
Bausch & Lomb Incorporated	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AcrySof MA50BM,AVS Model X-60	Other	AcrySof MA50BM, AVS Model X-60	Device: Intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraocular lens	Device		AcrySof MA50BM,AVS Model X-60

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.	Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.	The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Bilateral cataracts requiring surgery
Potential visual acuity of 20/40 or better in both eyes
Require IOL power in range of 15-25 diopters
Pupillary dilation of at least 6mm
Willing and able to provide informed consent and attend follow-up appointments to 3 years

Exclusion Criteria:

Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Luther Fry, MD	Fry Eye Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fry Eye Associates		Garden City	Kansas	67846	United States

ID	Term
D002386	Cataract

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D007910	Lenses, Intraocular

Ancestor Terms

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies
D019736	Prostheses and Implants

Browse Leaves

Not provided

Browse Branches

Not provided