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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03179397
• Other study ID #: SC9-0015
• Status: Terminated
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: July 22, 2023

Study information

• Verified date: August 2023
• Source: CORD, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 338
• Est. completion date: July 22, 2023
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Model SC9
Experimental
• Model LI61SE
Active Comparator

Locations

Country	Name	City	State
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Aker-Kasten Eye Center	Boca Raton	Florida
United States	Davies Eye Center	Carlsbad	California
United States	Fine, Hoffman and Sims	Eugene	Oregon
United States	Houston Eye Associates	Houston	Texas
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Harvard Eye Associates	Laguna Hills	California
United States	The Eye Institute of West Florida	Largo	Florida
United States	Center for Sight	Las Vegas	Nevada
United States	Coastal Vision Laser Eye Center	Orange	California
United States	Shasta Eye Medical Group, Inc.	Redding	California
United States	Eye Associates of South Texas	San Antonio	Texas
United States	Parkhurst NuVision	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CORD, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Defocus testing in 0.5D increments from -0.5 to -5.00D	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.	12 Months