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Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction. (AVS Vs MA50BM)

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ClinicalTrials.gov Identifier: NCT01131481
Recruitment Status : Withdrawn (lack of recruitment)
First Posted : May 27, 2010
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Fry Eye Associates and Fry Eye Surgery Center

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.

Condition or disease Intervention/treatment Phase
Glistenings Device: Intraocular lens Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.
Study Start Date : June 2010
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
AcrySof MA50BM,AVS Model X-60
AcrySof MA50BM, AVS Model X-60
Device: Intraocular lens



Primary Outcome Measures :
  1. Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company. [ Time Frame: 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. ]
    Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131481


Locations
United States, Kansas
Fry Eye Associates
Garden City, Kansas, United States, 67846
Sponsors and Collaborators
Fry Eye Associates and Fry Eye Surgery Center
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Luther Fry, MD Fry Eye Associates

Responsible Party: Luther L. Fry,M.D., Fry Eye Associates and Fry Eye Surgery Center
ClinicalTrials.gov Identifier: NCT01131481     History of Changes
Other Study ID Numbers: Protocol Number 7248
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: June 2011

Keywords provided by Fry Eye Associates and Fry Eye Surgery Center:
cataracts,glistenings,intraocular lenses.