Clinical Evaluation of a 1-Piece Intraocular Lens

NCT01098812 | Completed Phase 3 Results

• 1 other identifier: TIOL-103-TCNS
• Study Type: interventional
• Target: 269
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cataract

Keywords

Cataract, Intraocular lens

Outcome Measures

Primary Outcomes (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.

  6 months after second eye implant compared to baseline

Secondary Outcomes (1)

• Uncorrected Distance Visual Acuity (UCDVA)

  6 months after second eye implant

Study Arms (3)

Control IOL

ACTIVE COMPARATOR

Approved Intraocular control lens

Device: Tecnis ZCB00 IOL (control)

Toric IOL

EXPERIMENTAL

Investigational Toric IOL

Device: Toric Intraocular lens

Higher Cylinder Toric IOL

EXPERIMENTAL

Investigational Toric IOLs with higher cylinder powers.

Device: Toric Intraocular lens

Interventions

Tecnis ZCB00 IOL (control) DEVICE

Tecnis 1-piece acrylic IOL

Control IOL

Toric Intraocular lens DEVICE

Toric acrylic intraocular lens with various cylinder powers

Higher Cylinder Toric IOL; Toric IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Kristen Featherstone
• Organization: Abbott Medical Optics

kristen.featherstone@amo.abbott.com

714-247-8621

Study Officials

• Nicholas Tarantino, O.D.

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 5, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 4, 2025
• Results First Posted: July 2, 2013

Record last verified: 2025-01