About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Adults age 50 to 80 years
- In good general health at screening as determined by investigator
- Signed informed consent
- Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned
- Capsular bag size measured by UBM and determined to be a good fit for the Juvene IOL
- Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 either with or without a glare source present (e.g., Brightness Acuity Tester), or scheduled for cataract removal due to significant cataract-related symptoms/complaints
- Calculated IOL power is within the range of the investigational IOL
- Preoperative "against the rule" corneal astigmatism (steep@180°) of 1.50 D or less or preoperative "with the rule" corneal astigmatism (steep @90°) of 0.75 D or less.
- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
- Potential visual acuity of 20/32 or better in both eyes after cataract removal and IOL implantation as determined by diagnostic testing or investigator's judgement.
- No secondary procedures (such as LASIK) will be allowed during the term of the study
Exclusion Criteria
- Uncontrolled systemic or ocular disease incuding clinically diagnosed significant dry eye syndrome (DES)
- Subjects taking medications that may affect ocular function (including but not limited t to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents,)
- Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome))
- History of ocular trauma or prior ocular surgery
- Amblyopia or strabismus
- Any pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, glaucomatous optic neuropathy etc.)
- Keratoconus, pellucid corneal degeneration or other corneal dystrophy
- Irregular astigmatism
- Nystagmus
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative lens stability (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupil, abnormally shaped pupil, rubeosis iridis, aniridia, or iris coloboma), or pupils that don't dilate at least 6.0 mm pharmacologically.
- Any pre-existing ocular conditions such as pseudoexfoliation, chronic uveitis, corneal dystrophy, traumatic cataract, white cataracts which lead to radicalization of the capsulorhexis
- Women who are pregnant or plan on getting pregnant during the term of the study
- Concurrent participation in another drug or device investigation
- Subjects shall be excluded when certain conditions are present at the time of surgery including: