CataractNCT03179397
Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)
A study testing Model SC9 and Model LI61SE in people with Cataract, run by CORD, LLC at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Model SC9 and Model LI61SE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 13 sitesUnited States
- Study dates
- 31 May 2017to 22 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Chu Vision Institute
Bloomington, Minnesota, 55420
Aker-Kasten Eye Center
Boca Raton, Florida, 33432
Davies Eye Center
Carlsbad, California, 92008
Fine, Hoffman and Sims
Eugene, Oregon, 97401
Houston Eye Associates
Houston, Texas, 77008
Silverstein Eye Centers
Kansas City, Missouri, 64133
Harvard Eye Associates
Laguna Hills, California, 92653
The Eye Institute of West Florida
Largo, Florida, 33770
Center for Sight
Las Vegas, Nevada, 89145
Coastal Vision Laser Eye Center
Orange, California, 92868
Shasta Eye Medical Group, Inc.
Redding, California, 96001
Parkhurst NuVision
San Antonio, Texas, 78229
Eye Associates of South Texas
San Antonio, Texas, 78247
About this study
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
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Read the 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.
- Conditions
- Cataract
- Being tested
- Model SC9, Model LI61SE
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model SC9Device
Experimental
Model LI61SEDevice
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Model SC9 | Experimental | Investigational IOL Receives: Device: Model SC9 |
| Model LI61SE | Active comparator | FDA Approved IOL Receives: Device: Model LI61SE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Secondary outcomes (1)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start31 May 2017
- Primary completion4 Oct 2021
- Study completion22 Jul 2023
Why it stopped: Sponsor did not recruit enough subjects to file PMA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- CORD, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hovanesian, M.D., Study chair, CORD, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179397
- Sponsor's protocol ID
- SC9-0015
- Status last verified
- Aug 2023
- First submitted
- 29 May 2017
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03179397
- Acronym / sponsor ID
- SC9-0015
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor did not recruit enough subjects to file PMA.
- Enrolment
- 338 participants (actual)
- Lead sponsor
- CORD, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model SC9 | Experimental | Device: Model SC9Investigational IOL |
| Model LI61SE | Active comparator | Device: Model LI61SEFDA Approved IOL |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model SC9Experimental | Device | Model SC9 |
| Model LI61SEActive Comparator | Device | Model LI61SE |
Primary outcome
Improvement in Visual Acuity Measurements using the LogMar Scale
Time frame: 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
1 secondary outcome
Defocus testing in 0.5D increments from -0.5 to -5.00D
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Sponsor did not recruit enough subjects to file PMA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hovanesian, M.D. study chair
CORD, LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model SC9 and Model LI61SE in people with Cataract, run by CORD, LLC at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor did not recruit enough subjects to file PMA.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Visual Acuity Measurements using the LogMar Scale (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.