VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

Cataract Clinical Trial

— ORION  

Official title:

VisiOn Restoration With the FluidVisION AIOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925545
• Other study ID #: CTP07700
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: November 27, 2018

Study information

• Verified date: May 2021
• Source: PowerVision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

Description:

This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Inclusion Criteria:

• Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;

• Preoperative or predicted postoperative astigmatism of = 1.0 diopter (D);

• Calculated IOL power within range.

Key Exclusion Criteria:

• Current medication that may affect accommodation;

• Systemic disease or concomitant medication that may increase operative risk or confound results;

• Ocular conditions that may predispose the subject for future complications;

• Monocular subjects or subjects with significant permanent visual function loss in fellow eye;

• Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;

• Grade 4 cataract of any type.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• FluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
• AcrySof IQ monofocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Procedure:
• Cataract surgery
Standard cataract extraction with phacoemulsification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PowerVision

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodative Amplitude (AA)	Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.	Month 6 postoperative
Primary	Distance Corrected Visual Acuity	Visual acuity was measured with distance correction (plus or minus power) in place.	Month 6 postoperative
Primary	International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL	Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.	Up to Month 6 postoperative
Secondary	Accommodative Amplitude	Accommodative amplitude is a measure of the range of vision with good acuity.	Month 3 postoperative
Secondary	Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity	Plus lenses were placed over the subject's best distance manifest correction.	Up to Month 6 postoperative
Secondary	Uncorrected Visual Acuity	Visual acuity was measured without correction in place.	Up to Month 6 postoperative