Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Primary Purpose
Aphakia, Presbyopia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Alcon Fluid Accommodating Intraocular Lens
Top Con Autorefractor
Sponsored by
About this trial
This is an interventional other trial for Aphakia focused on measuring IOL, Cataract, Accommodation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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
Sites / Locations
- Alcon Investigator 8071
- Alcon Investigator 8165
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FAIOL
Arm Description
Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.
Outcomes
Primary Outcome Measures
Repeatability of objective refraction
Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04330001
Brief Title
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Official Title
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
May 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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 IOL (FAIOL).
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 surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Presbyopia
Keywords
IOL, Cataract, Accommodation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FAIOL
Arm Type
Experimental
Arm Description
Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.
Intervention Type
Device
Intervention Name(s)
Alcon Fluid Accommodating Intraocular Lens
Other Intervention Name(s)
FAIOL, FluidVision MX Accommodating IOL
Intervention Description
Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.
Intervention Type
Other
Intervention Name(s)
Top Con Autorefractor
Intervention Description
Device intended to automatically determine the focusing characteristics of the eye
Primary Outcome Measure Information:
Title
Repeatability of objective refraction
Description
Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).
Time Frame
Month 1 (post 2nd eye implant)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Operation Lead CDMA Surgical
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 8071
City
San Salvador
ZIP/Postal Code
4625
Country
El Salvador
Facility Name
Alcon Investigator 8165
City
Panamá
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
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