NCT01131481

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 15, 2015

Status Verified

June 1, 2011

Enrollment Period

3 years

First QC Date

May 26, 2010

Last Update Submit

September 14, 2015

Conditions

Glistenings

Keywords

cataracts,glistenings,intraocular lenses.

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

AcrySof MA50BM,AVS Model X-60

OTHER

AcrySof MA50BM, AVS Model X-60

Device: Intraocular lens

Interventions

Intraocular lensDEVICE
AcrySof MA50BM,AVS Model X-60

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fry Eye Associates

Garden City, Kansas, 67846, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Luther Fry, MD

    Fry Eye Associates

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

September 15, 2015

Record last verified: 2011-06

Locations

US(1)