Study Stopped
Sponsor did not recruit enough subjects to file PMA.
Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)
A Clinical Trial to Evaluate the Safety and Effectiveness of Model SC9 Silicone IOL for the Visual Correction of Aphakia Secondary to the Removal of a Cataractous Lens in Adult Patients With or Without Presbyopia
1 other identifier
interventional
338
1 country
13
Brief Summary
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2017
CompletedStudy Start
First participant enrolled
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2023
CompletedAugust 30, 2023
August 1, 2023
4.3 years
May 29, 2017
August 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in Visual Acuity Measurements using the LogMar Scale
Subjects must read 20/40 or better, distance corrected near visual acuity and 20/40 or better distance corrected intermediate visual acuity. This is achieved with the subject wearing their best corrected spectacle correction in place and reading a series of letters at 40cm/16" and 80cm/32". Total letters read for each line will determine their visual acuity
12 Months
Secondary Outcomes (1)
Defocus testing in 0.5D increments from -0.5 to -5.00D
12 Months
Study Arms (2)
Model SC9
EXPERIMENTALInvestigational IOL
Model LI61SE
ACTIVE COMPARATORFDA Approved IOL
Interventions
Eligibility Criteria
You may qualify if:
- Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts
- Able to comprehend and sign a statement of informed consent
- Willing and able to complete all required postoperative visits
- Calculated Lens Power within the available range for the study IOL's
- Planned cataract removal by phacoemulsification
- Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes
- Subjects with less than 1.0D of corneal astigmatism
- Clear intraocular media other than cataract in the study eye
- Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare
- Pupil size greater or equal to 6.0mm after dilation
You may not qualify if:
- Any corneal abnormality, other than regular corneal astigmatism
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32)
- Previous refractive surgery
- Amblyopia
- Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
- Diabetic retinopathy
- Extremely shallow anterior chamber, not due to swollen cataract
- Microphthalmos
- Previous retinal detachment
- Previous corneal surgery
- Recurrent severe anterior or posterior segment inflammation of unknown etiology
- Rubella or traumatic cataract
- Iris Neovascularization
- Glaucoma (uncontrolled or controlled with medication)
- Aniridia
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CORD, LLClead
Study Sites (13)
Davies Eye Center
Carlsbad, California, 92008, United States
Harvard Eye Associates
Laguna Hills, California, 92653, United States
Coastal Vision Laser Eye Center
Orange, California, 92868, United States
Shasta Eye Medical Group, Inc.
Redding, California, 96001, United States
Aker-Kasten Eye Center
Boca Raton, Florida, 33432, United States
The Eye Institute of West Florida
Largo, Florida, 33770, United States
Chu Vision Institute
Bloomington, Minnesota, 55420, United States
Silverstein Eye Centers
Kansas City, Missouri, 64133, United States
Center for Sight
Las Vegas, Nevada, 89145, United States
Fine, Hoffman and Sims
Eugene, Oregon, 97401, United States
Houston Eye Associates
Houston, Texas, 77008, United States
Parkhurst NuVision
San Antonio, Texas, 78229, United States
Eye Associates of South Texas
San Antonio, Texas, 78247, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Hovanesian, M.D.
CORD, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Enrolled subjects will not be told which IOL they have received until the end of the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 7, 2017
Study Start
May 31, 2017
Primary Completion
October 4, 2021
Study Completion
July 22, 2023
Last Updated
August 30, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share