Clinical trial NCT03350503: AcrySof IQ Toric A-Code Post-Market Clinical Study
Official title: AcrySof IQ Toric A-Code Post-Market Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Astigmatism
Keywords: phacoemulsification
intraocular lens
vision
toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 125
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 clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.

Detailed description: Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cataracts with planned cataract removal by phacoemulsification
* Calculated lens power within the available range
* Able to sign informed consent and complete all study visits
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye conditions as specified in the protocol
* Uncontrolled glaucoma
* Pregnancy, current or planned
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
timeFrame: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)
Secondary outcomes:
Other outcomes:
measure: Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
timeFrame: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Mean Absolute Value of IOL Rotation From Visit 00
timeFrame: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit
timeFrame: Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit
timeFrame: Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit
timeFrame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Mean SSNG Densitometry (Area Analysis) by Visit
timeFrame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Number of Device Deficiencies
timeFrame: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Percentage of Eyes With Glistening by Visit
timeFrame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)
measure: Number of Eyes With Posterior Capsule Opacification (PCO) by Visit
timeFrame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7
measure: Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit
timeFrame: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7
Locations:
city: Hiroshima
country: Japan
facility: Alcon Investigative Site
state: Hiroshima Prefecture
city: Hakodate
country: Japan
facility: Alcon Investigative Site
state: Hokkaido
city: Miyakonojō
country: Japan
facility: Alcon Investigative Site
state: Miyazaki Prefecture
city: Saga
country: Japan
facility: Alcon Investigative Site
state: Saga Prefecture
Study officials:
affiliation: Alcon Research, LLC
name: Expert Clinical Project Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: