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

Sponsor
Fry Eye Associates and Fry Eye Surgery Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01131481
Collaborator
Bausch & Lomb Incorporated (Industry)
0
Enrollment
1
Location
1
Arm
37
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Intraocular lens
 Phase 4

Study Design

Study Type:
Interventional
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 :
Jun 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2013
Anticipated Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: AcrySof MA50BM,AVS Model X-60

AcrySof MA50BM, AVS Model X-60

Device: Intraocular lens

Outcome Measures

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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01131481
Other Study ID Numbers:
  • Protocol Number 7248
First Posted:
May 27, 2010
Last Update Posted:
Sep 15, 2015
Last Verified:
Jun 1, 2011
Keywords provided by , ,
cataracts,glistenings,intraocular lenses.
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Sep 15, 2015