Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

Sponsor
CORD, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03179397
Collaborator
(none)
338
Enrollment
13
Locations
2
Arms
76
Anticipated Duration (Months)
26
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Model SC9
  • Device: Model LI61SE
N/A

Detailed Description

Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb).

Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects).

Subjects will be followed for 36 Months.

Study Design

Study Type:
Interventional
Actual Enrollment :
338 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Enrolled subjects will not be told which IOL they have received until the end of the study
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
May 31, 2017
Actual Primary Completion Date :
Oct 4, 2021
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Model SC9

Investigational IOL

Device: Model SC9
Experimental

Active Comparator: Model LI61SE

FDA Approved IOL

Device: Model LI61SE
Active Comparator

Outcome Measures

Primary Outcome Measures

  1. Improvement in Visual Acuity Measurements using the LogMar Scale [12 Months]

    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

Secondary Outcome Measures

  1. Defocus testing in 0.5D increments from -0.5 to -5.00D [12 Months]

    A sub-set of 50 subjects will undergo defocus testing with their best distance correction in place. Minus Lenses in 0.5D increments will be placed over their best spectacle correction. Total letters read for each diopter will be recorded. Percentage of eyes with improvement of monocular depth of focus by at least 0.5D mean difference between the Model SC9 and control lens.(significance level of 0.025). To demonstrate superiority of at least 0.5D compared to the control lens >75% of eyes implanted with the Model SC9 should demonstrate superiority by at least 0.5D mean difference compared to the control lens.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

  • Optic nerve atrophy

  • Damaged incomplete zonules

  • Systemic disease that could increase the operative risk or confound the outcome

  • Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Davies Eye CenterCarlsbadCaliforniaUnited States92008
2Harvard Eye AssociatesLaguna HillsCaliforniaUnited States92653
3Coastal Vision Laser Eye CenterOrangeCaliforniaUnited States92868
4Shasta Eye Medical Group, Inc.ReddingCaliforniaUnited States96001
5Aker-Kasten Eye CenterBoca RatonFloridaUnited States33432
6The Eye Institute of West FloridaLargoFloridaUnited States33770
7Chu Vision InstituteBloomingtonMinnesotaUnited States55420
8Silverstein Eye CentersKansas CityMissouriUnited States64133
9Center for SightLas VegasNevadaUnited States89145
10Fine, Hoffman and SimsEugeneOregonUnited States97401
11Houston Eye AssociatesHoustonTexasUnited States77008
12Parkhurst NuVisionSan AntonioTexasUnited States78229
13Eye Associates of South TexasSan AntonioTexasUnited States78247

Sponsors and Collaborators

  • CORD, LLC

Investigators

  • Study Chair: J Stuart Cumming, M.D., CORD, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CORD, LLC
ClinicalTrials.gov Identifier:
NCT03179397
Other Study ID Numbers:
  • SC9-0015
First Posted:
Jun 7, 2017
Last Update Posted:
Nov 23, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021