Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb) (NCT03179397) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)
Stopped: Sponsor did not recruit enough subjects to file PMA.
United States338 participantsStarted 2017-05-31
Plain-language summary
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Improvement in Visual Acuity Measurements using the LogMar Scale