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OpenTrials
Completed

NCT Number: NCT00762021

Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens

To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with bilateral senile cataracts
  • Age > 50 years
  • Fit for hospital follow ups
  • Pupils dilating > 6mm preoperatively
  • Eyes expected to see 6/12 or better postoperatively

Exclusion criteria

  • Diabetes
  • On treatment for glaucoma
  • Other ocular pathology
  • Previous ocular surgery

Treatment and study plan

SN60AT

Device

Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.

SN60WF

Device

Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.

Primary outcomes

  1. Posterior Capsule Opacification (PCO)

    Time frame: 2 years after surgery

    Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.

  2. 100% LogMAR Best Corrected Visual Acuity (BCVA)

    Time frame: 24 months after surgery

    Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.

    VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

  3. 9% LogMAR Best Corrected Visual Acuity (BCVA)

    Time frame: 24 months after surgery

    Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.

    VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
First posted
Sep 30, 2008
Registry last updated
Dec 22, 2010

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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