AcrySof IQ Toric A-Code Post-Market Clinical Study
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03350503
Collaborator
(none)
125
4
1
46.6
31.3
0.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
An interim analysis of results through Visit 4 (Day 120-180) is provided.
Study Design
Study Type:
Interventional
Actual Enrollment
:
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AcrySof IQ Toric A-Code Post-Market Clinical Study
Actual Study Start Date
:
Jan 30, 2018
Actual Primary Completion Date
:
May 23, 2019
Actual Study Completion Date
:
Dec 17, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acrysof IQ Toric A-code IOL IOL implanted during cataract surgery |
Device: AcrySof IQ Toric A-code IOL
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
Other Names:
Procedure: Cataract surgery
Removal of cataractous lens and implantation of IOL
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Absolute Intraocular (IOL) Rotation (Visit 00 to Visit 4) [Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)]
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Hiroshima | Hiroshima Prefecture | Japan | 733-0842 |
| 2 | Alcon Investigative Site | Hakodate | Hokkaido | Japan | 040-0053 |
| 3 | Alcon Investigative Site | MiyakonojĊ | Miyazaki Prefecture | Japan | 885-0051 |
| 4 | Alcon Investigative Site | Saga | Saga Prefecture | Japan | 840-0831 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Expert Clinical Project Lead, CDMA Surgical, Alcon Research, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03350503
Other Study ID Numbers:
- ILV814-P001
First Posted:
Nov 22, 2017
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Of the 125 subjects enrolled, 4 were exited as screen failures. This reporting group includes all subjects with successful test article implantation unilaterally (121 subjects). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AcrySof IQ Toric A-code IOL |
|---|---|
| Arm/Group Description | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally |
| Period Title: Overall Study | |
| STARTED | 121 |
| COMPLETED | 116 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | Acrysof IQ Toric A-code IOL |
|---|---|
| Arm/Group Description | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally |
| Overall Participants | 121 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
75.5
(7.0)
|
| Age, Customized (Count of Participants) | |
| Less than 60 years |
2
1.7%
|
| 60 to 69 years |
14
11.6%
|
| 70 to 79 years |
69
57%
|
| Equal to or greater than 80 years |
36
29.8%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
67
55.4%
|
| Male |
54
44.6%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Japanese |
121
100%
|
| Region of Enrollment (participants) [Number] | |
| Japan |
121
100%
|
Outcome Measures
| Title | Number of Participants With Absolute Intraocular (IOL) Rotation (Visit 00 to Visit 4) |
|---|---|
| Description | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted. |
| Time Frame | Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with successful test article implantation and measurable data at Visit 4. |
| Arm/Group Title | Acrysof IQ Toric A-code IOL |
|---|---|
| Arm/Group Description | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally |
| Measure Participants | 115 |
| Less than 10 degrees |
114
94.2%
|
| Less than 20 degrees |
115
95%
|
| Less than 30 degrees |
115
95%
|
Adverse Events
| Time Frame | Adverse events are reported up to Visit 4 (Day 120-180) as an interim analysis. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye). | |
| Arm/Group Title | Acrysof IQ Toric A-code IOL | |
| Arm/Group Description | AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally | |
All Cause Mortality |
||
| Acrysof IQ Toric A-code IOL | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/121 (0.8%) | |
Serious Adverse Events |
||
| Acrysof IQ Toric A-code IOL | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/121 (4.1%) | |
| Gastrointestinal disorders | ||
| Haemmorhoids | 1/121 (0.8%) | |
| Infections and infestations | ||
| Pneumonia | 1/121 (0.8%) | |
| Injury, poisoning and procedural complications | ||
| Compression fracture | 1/121 (0.8%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung neoplasm malignant | 1/121 (0.8%) | |
| Nervous system disorders | ||
| Cerebral infarction | 1/121 (0.8%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Interstitial lung disease | 1/121 (0.8%) | |
Other (Not Including Serious) Adverse Events |
||
| Acrysof IQ Toric A-code IOL | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/121 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Expert Clinical Project Lead, CDMA Surgical |
|---|---|
| Organization | Alcon Research |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03350503
Other Study ID Numbers:
- ILV814-P001
First Posted:
Nov 22, 2017
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022