Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Presbyopia Clinical Trial

Official title:

Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330001
• Other study ID #: ILR286-E003
• Status: Completed
• Phase: N/A
• Start date: December 28, 2020
• Est. completion date: May 3, 2023

Study information

• Verified date: May 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 3, 2023
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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:

1. are currently pregnant,

2. have a positive urine pregnancy test result at V0,

3. intend to become pregnant during the study period,

4. 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

Related Conditions & MeSH terms

• Aphakia
• Presbyopia

Intervention

Device:
• Alcon Fluid Accommodating Intraocular Lens
Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.

Other:
• Top Con Autorefractor
Device intended to automatically determine the focusing characteristics of the eye

Locations

Country	Name	City	State
El Salvador	Alcon Investigator 8071	San Salvador
Panama	Alcon Investigator 8165	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

El Salvador,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Month 1 (post 2nd eye implant)