Status:
COMPLETED
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Presbyopia
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating ...
Detailed Description
Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surg...
Eligibility Criteria
Inclusion
- Willing and able to attend all scheduled study visits as required per protocol
- 22 years of age or older
- Bilateral cataracts
- Corneal astigmatism ≤ 1.25 D
- Clear intraocular media other than cataract
- Other protocol-specified inclusion criteria may apply.
Exclusion
- Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:
- are currently pregnant,
- have a positive urine pregnancy test result at V0,
- intend to become pregnant during the study period,
- are breast-feeding.
- Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
- Glaucoma
- Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
- Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
- Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study
- Systemic disease that could increase the operative risk or confound the outcome
- Other protocol-specified exclusion criteria may apply
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2023
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04330001
Start Date
December 28 2020
End Date
May 3 2023
Last Update
May 6 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Alcon Investigator 8071
San Salvador, El Salvador, 4625
2
Alcon Investigator 8165
Panama City, Panama