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Clinical Trials/NCT00838045
NCT00838045CompletedPhase 4

A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens

Bausch & Lomb Incorporated2 sites in 1 country125 target enrollmentStarted: September 2006Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
125
Locations
2
Primary Endpoint
Bast Corrected Visual Acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
  • •Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
  • •Subjects must require a lens power from 15 to 30 diopters.
  • •Subjects must have a visual potential of 20/40 or better in the study eye.

Exclusion Criteria

  • •Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
  • •Subjects with any inflammation or edema (swelling) of the cornea.
  • •Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
  • •Subjects with previous retinal detachment.
  • •Subjects with diabetic retinopathy (proliferative or non-proliferative).
  • •Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
  • •Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
  • •Subjects who have already received an Akreos TL IOL in the fellow eye.

Outcomes

Primary Outcomes

Bast Corrected Visual Acuity

Time Frame: 24 months

best-corrected visual acuity (BCVA)

Secondary Outcomes

  • Uncorrected Visual Acuity(24 months)
  • Manifest Refraction(24 Months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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