Study Stopped
Sponsor stopped study to re-design trial
Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery
1 other identifier
interventional
75
1 country
1
Brief Summary
This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 24, 2010
CompletedFirst Posted
Study publicly available on registry
November 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedOctober 18, 2018
March 1, 2014
1.3 years
November 24, 2010
October 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target versus Achieved Refraction
3 Months Postoperative
Secondary Outcomes (1)
Uncorrected Visual Acuity
3 Months Postoperative
Study Arms (2)
Tecnis Z9002 Intraocular Lens (IOL)
ACTIVE COMPARATORSoftec HD Intraocular Lens (IOL)
ACTIVE COMPARATORInterventions
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
Eligibility Criteria
You may qualify if:
- operable cataracts in both eyes
- require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
- \</=1 diopter (D) of regular astigmatism in both eyes
You may not qualify if:
- Intraocular surgery or laser treatment prior to cataract surgery
- Severe dry eye
- Presence of ocular infection
- Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
- Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
- History of retinal detachment
- Corneal decompensation
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Luke's Cataract & Laser Institute
Tarpon Springs, Florida, 34689, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Pitzer Gills, III, MD
St. Luke's Cataract and Laser Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
November 24, 2010
First Posted
November 29, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 18, 2018
Record last verified: 2014-03