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OpenTrials
Completed

NCT Number: NCT00786565

Clinical Evaluation of a New Aspheric Intraocular Lens.

This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
  • Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

Exclusion criteria

  • Patients with corneal damage.
  • Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
  • Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Treatment and study plan

Advanced Akreos Adapt in one operated eye.

Device

Cataract surgery to implant the assigned IOL according to randomized schedule.

Akreos Adapt in fellow operated eye.

Device

Cataract surgery to implant the assigned IOL according to randomized schedule.

Primary outcomes

  1. Low Contrast Best Corrected Visual Acuity Following Cataract Surgery

    Time frame: 3 months

    Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.

  2. Low Contrast Uncorrected Visual Acuity Following Cataract Surgery

    Time frame: 3 months

    Low contrast uncorrected visual acuity 3 months post cataract surgery

  3. Photopic Contrast Sensitivity

    Time frame: 3 months

    The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  4. Mesoptic Contrast Sensitivity

    Time frame: 3 Months

    The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  5. Posterior Capsule Opacification Score

    Time frame: 24 months

    Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.

Secondary outcomes

  1. High Contrast Visual Acuity

    Time frame: 1 month

    High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.

  2. High Contrast Visual Acuity Uncorrected

    Time frame: 3 months

  3. High Contrast Visual Acuity Best Corrected

    Time frame: 3 months

  4. High Contrast Visual Acuity

    Time frame: 12 months

  5. High Contrast Visual Acuity Uncorrected

    Time frame: 24 Months

  6. High Contrast Visual Acuity Best Corrected

    Time frame: 24 Months

  7. Low Contrast Visual Acuity

    Time frame: 1 month

    Uncorrected Low contrast visual acuity - LogMar visual acuity value

  8. Contrast Sensitivity Photopic 1.5cpd

    Time frame: 1 month

    The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  9. Contrast Sensitivity Photopic

    Time frame: 1 month

    The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  10. Contrast Sensitivity Mesoptic 1.5 Cpd

    Time frame: 1 month

    The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  11. Contrast Sensitivity Mesoptic

    Time frame: 1 month

    The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  12. Posterior Capsule Opacification

    Time frame: 12 months

    Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2008
Registry last updated
Dec 12, 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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