Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
| City: |
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Rome |
| State: |
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Georgia |
| Zip Code: |
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30165 |
| Conditions: |
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Cataract |
| Purpose: |
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The primary goal of this study is to determine the effective lens position (ELP) - or
location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary
study goal is to determine if measures of the eye taken prior to surgery can reliably
predict postoperative ELP.
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| Study Summary: |
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The primary objective of this study is to determine the effective lens position (ELP) of the
study lens, and to report the stability of ELP post-operatively. Additionally, correlations
of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry
and age will be statistically analysed for determination of ELP prediction via one, or a
combination of preoperative variables.
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| Criteria: |
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Inclusion Criteria:
- >=40 years of age, of any race and either gender
- Operable, age related cataract grade 3+ or lower in the study eye
- Able to achieve BCVA 20/30 or better postoperatively in the study eye
- ≤1.0 D of corneal astigmatism preoperatively in the study eye
- Able to achieve a dilated pupil >6.0 mm in the study eye
- Able to adequately visualize the lens equatorial diameter on the UBM (preoperatively)
- Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
- In good general and ocular health
- Able to competently complete testing
- Willing and able to attend study visits
- Willing and able to understand and sign an informed consent
Exclusion Criteria:
- Previous intraocular surgery or laser treatment
- Severe dry eye
- Uncontrolled IOP or glaucoma
- Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic
retinopathy, etc.)
- History of retinal detachment
- Microphthalmia
- Chronic severe uveitis
- Corneal decompensation
- Irregular astigmatism
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Pseudoexfoliation syndrome
- Iris atrophy
- Pupil abnormalities (e.g., corectopia)
- Aniseikonia
- Amblyopia
- An acute or chronic disease or illness that may confound the results of this
investigation (e.g., immunocompromised, connective tissue disease, clinically
significant atopic disease, diabetes, and any other such disease or illness)
- Pregnant, lactating, or planning to become pregnant during the course of the trial
- Participation in another clinical trial within 30 days of study start
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| NCT ID: |
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NCT01248572 |
| Primary Contact: |
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Erin Hayes, MS
Phone: 727-571-2272
Email: ehayes@lenstec.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rome, Georgia 30165
United States
Cherilyn Donovan, RN
Phone: 706-236-6321
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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