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

Glistenings Clinical Trial

— AVS Vs MA50BM  

Official title:

Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01131481
• Other study ID #: Protocol Number 7248
• Status: Withdrawn
• Phase: Phase 4
• First received: May 26, 2010
• Last updated: September 14, 2015
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: June 2011
• Source: Fry Eye Associates and Fry Eye Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Glistenings

Intervention

Device:
• Intraocular lens

Locations

Country	Name	City	State
United States	Fry Eye Associates	Garden City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Fry Eye Associates and Fry Eye Surgery Center	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No