Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Cataract Clinical Trial

Official title:

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090256
• Other study ID #: ILH297-C003
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: February 13, 2018

Study information

• Verified date: August 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Description:

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 13, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Able to comprehend and sign a statement of informed consent;

• Willing and able to complete all required postoperative visits;

• Cataracts in both eyes with planned cataract removal by phacoemulsification;

• Calculated lens power within the available range;

• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;

• Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion Criteria:

• Significant irregular corneal aberration as demonstrated by corneal topography;

• Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;

• Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;

• Previous refractive surgery;

• Diabetic retinopathy

• Other eye conditions as specified in the protocol

• Pregnant.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof® IQ PanOptix™ IOL
Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
Japan	Alcon Investigative Site	Fukuoka
Japan	Alcon Investigative Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Photopic Best Corrected Distance Visual Acuity (5 m)	Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Primary	Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)	VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Primary	Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)	VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation