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OpenTrials
Completed

NCT Number: NCT00838045

Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

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.

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Key information

Conditions

Cataract Aphakia Eye Diseases Lens Diseases

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum der J.W. Goethe-Universität

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

Device

Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.

Primary outcomes

  1. Bast Corrected Visual Acuity

    Time frame: 24 months

    best-corrected visual acuity (BCVA)

Secondary outcomes

  1. Uncorrected Visual Acuity

    Time frame: 24 months

  2. Manifest Refraction

    Time frame: 24 Months

    mean manifest refraction

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2009
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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