Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
Detailed Description
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.
This study will be conducted in Japan.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
- •Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Irregular corneal astigmatism.
- •History of anterior segment, posterior segment, or optic nerve pathology.
- •History of previous intraocular or corneal (refractive or trauma related) surgery.
- •Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Time Frame: Day 30-60 postoperative
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Secondary Outcomes
- Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)(Day 30-60 postoperative)
- Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)(Day 30-60 postoperative)