Status:
COMPLETED
IOL Implantation After KAMRA Inlay Removal
Lead Sponsor:
AcuFocus, Inc.
Conditions:
Cataract
Presbyopia
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal. B. The secondary ...
Detailed Description
This will be a prospective study in which no more than 20 subjects will be implanted with IC-8 IOL following the removal of the KAMRA inlay. The refractive target of the IC-8 eye will be -0.75 D MRSE....
Eligibility Criteria
Inclusion
- i. Subjects must sign and be given a copy of the informed consent form. ii. Subjects with BCDVA of 20/40 or worse, or significant visual symptoms/complaints as a result of cataract in the study eye.
- iii. Subjects must be \> 45 years of age at the time of screening. iv. Subjects must be willing and able to return for scheduled follow up examinations for 12 months after surgery.
- v. Subjects who underwent uneventful KAMRA inlay implantation and who currently still have the inlay in the eye.
- vi. Potential visual acuity following cataract removal and IOL implantation projected to be 0.8 or better (Snellen 20/25) as determined by diagnostic testing or investigator's medical judgment.
Exclusion
- i. Patients who had any type of intraocular surgery or refractive surgery (with the exception of KAMRA inlay implantation).
- ii. Requiring an intraocular lens outside the available power range of +15.5 to +27.5 diopters.
- iii. Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos.
- iv. Preoperative corneal astigmatism \> 1.5 diopters (as determined by corneal topography or keratometry in either eye) or irregular corneal astigmatism.
- v. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.8 or worse during the study.
- vi. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, etc.).
- vii. Glaucoma suspect, uncontrolled ocular hypertension, or history of glaucomatous changes in the retina or visual field.
- viii. Subjects with uncontrolled systemic disease. ix. Subjects with previous retinal pathology in either eye.
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03320473
Start Date
December 5 2017
End Date
June 20 2022
Last Update
May 10 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asian Eye Institute
Makati City, Philippines, 1200