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

This study has been withdrawn prior to enrollment.
(lack of recruitment)
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Fry Eye Associates and Fry Eye Surgery Center
ClinicalTrials.gov Identifier:
NCT01131481
First received: May 26, 2010
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Glistenings
Device: Intraocular lens
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.

Resource links provided by NLM:


Further study details as provided by Fry Eye Associates and Fry Eye Surgery Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.


Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AcrySof MA50BM,AVS Model X-60
AcrySof MA50BM, AVS Model X-60
Device: Intraocular lens

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 26, 2010
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014