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CataractPhase 3NCT01098812

Clinical Evaluation of a 1-Piece Intraocular Lens

A Phase 3 study testing Toric Intraocular lens in people with Cataract, run by Abbott Medical Optics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aims of this study are to: Demonstrate a reduction in postoperative cylinder compared to results from the control lens Demonstrate better uncorrected distance visual acuity compared to the control lens Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Toric Intraocular lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
No sites listed yet
Study dates
Mar 2010to Oct 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Minimum 18 years of age
  • Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes
  • Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye
  • BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye
  • Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL)
  • Clear intraocular media other than cataract in both eyes
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
  • Signed informed consent and HIPAA authorization

Who cannot join

  • Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters
  • Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye
  • Previous corneal or intraocular surgery in either eye
  • Irregular corneal astigmatism in either eye
  • Corneal pathology/abnormality potentially affecting topography in either eye
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye
Show all 18Show fewer
  • Inability to achieve keratometric stability in either eye for contact lens wearers
  • Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
  • An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure
  • Use of systemic or ocular medications that may affect vision
  • Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure
  • Poorly-controlled diabetes
  • Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
  • Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye
  • Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial

About this study

Official title: Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens

The aims of this study are to:

  • Demonstrate a reduction in postoperative cylinder compared to results from the control lens
  • Demonstrate better uncorrected distance visual acuity compared to the control lens
Conditions
Cataract
Being tested
Tecnis ZCB00 IOL (control), Toric Intraocular lens
Keywords
Cataract, Intraocular lens
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tecnis ZCB00 IOL (control)Device

    Tecnis 1-piece acrylic IOL

  • Toric Intraocular lensDevice

    Toric acrylic intraocular lens with various cylinder powers

Study groups in NCT01098812
Study groupRoleWhat they receive
Control IOLActive comparatorApproved Intraocular control lens
Receives: Device: Tecnis ZCB00 IOL (control)
Toric IOLExperimentalInvestigational Toric IOL
Receives: Device: Toric Intraocular lens
Higher Cylinder Toric IOLExperimentalInvestigational Toric IOLs with higher cylinder powers.
Receives: Device: Toric Intraocular lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Reduction in Cylinder

    Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.

    Measured: 6 months after second eye implant compared to baseline

Secondary outcomes (1)

  1. Uncorrected Distance Visual Acuity (UCDVA)

    Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.

    Measured: 6 months after second eye implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098812
Sponsor's protocol ID
TIOL-103-TCNS
Status last verified
Jan 2025
First submitted
31 Mar 2010
Last updated
4 Feb 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toric Intraocular lens in people with Cataract, run by Abbott Medical Optics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Reduction in Cylinder (time frame: 6 months after second eye implant compared to baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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