Clinical trial NCT03090256: Clinical Investigation of the AcrySof® IQ PanOptix™ IOL
Official title: Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Trifocal IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
timeFrame: 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
measure: Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
timeFrame: 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
measure: Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Alcon Investigative Site
city: Tokyo
country: Japan
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Japan, Ltd.
name: Group Manager, Clinical Development
role: STUDY_DIRECTOR
References: