CompletedNot Applicable

ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

United States15 participantsStarted 2009-08

Plain-language summary

The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts; * Calculated lens power is within the available range; * Willing and able to complete all required postoperative visits; * Planned cataract removal by phacoemulsification; * Potential postoperative visual acuity of 0.2 logMAR or better in study eyes; * Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study; * Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye; * Clear intraocular media other than cataract; * Able to comprehend and sign a statement of informed consent; * Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR; * Pupil size greater than or equal to 6 mm after dilation; * The subject must be able to undergo second eye surgery within 30 days of first eye surgery. Exclusion Criteria: * Irregular corneal astigmatism; * Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana; * Any inflammation…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment

Timeframe: Before Surgery and 180 days after second eye implant

Reduction of Cylinder

Timeframe: 6 months after surgery on second eye

Lens Axis Misalignment

Timeframe: Time of surgery

Trial details

NCT IDNCT00967473

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2011-06-23

View on ClinicalTrials.gov More Bilateral Cataract trials