Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PanOptix Toric Trifocal IOL ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted. |
Device: ACRYSOF IQ PanOptix Toric Trifocal IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism
Other Names:
Procedure: Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
|
Outcome Measures
Primary Outcome Measures
- Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) [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 Outcome Measures
- Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) [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. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
- Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) [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. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Eligibility Criteria
Criteria
Key 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.
Key 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Chiyoda-Ku | Tokyo | Japan | 101-0061 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Japan Limited
Study Documents (Full-Text)
More Information
Publications
None provided.- ILX140-C001
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 1 investigative site located in Japan. |
|---|---|
| Pre-assignment Detail | This reporting group includes all enrolled participants. |
| Arm/Group Title | PanOptix Toric Trifocal IOL |
|---|---|
| Arm/Group Description | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Period Title: Overall Study | |
| STARTED | 32 |
| Attempted Implantation | 32 |
| Successful Implantation | 32 |
| COMPLETED | 32 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | PanOptix Toric Trifocal IOL |
|---|---|
| Arm/Group Description | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Overall Participants | 32 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65.2
(9.4)
|
| Age, Customized (participants) [Number] | |
| Less than 60 years |
8
25%
|
| 60-69 years |
10
31.3%
|
| 70-79 years |
13
40.6%
|
| 80 years and older |
1
3.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
25
78.1%
|
| Male |
7
21.9%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Japanese |
32
100%
|
| Region of Enrollment (participants) [Number] | |
| Japan |
32
100%
|
Outcome Measures
| Title | Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) |
|---|---|
| Description | 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. |
| Time Frame | Day 30-60 postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Implanted Analysis Set |
| Arm/Group Title | PanOptix Toric Trifocal IOL |
|---|---|
| Arm/Group Description | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Measure Participants | 32 |
| Measure eyes | 41 |
| Number [percentage of eyes] |
90.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PanOptix Toric Trifocal IOL |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Exact Test of Binomial Proportion | |
| Comments | ||
| Other Statistical Analysis | P-value is provided from exact test of binomial proportion (one-sided alpha = 2.5%) comparing PanOptix Toric Trifocal IOL Model TFNT20 with historical threshold 29.2 % (rate calculated for a non-toric IOL in Japanese study patients that would qualify for a T2 lens using the same toric calculator). | |
| Title | Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) |
|---|---|
| Description | 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. No confirmatory statistical hypothesis testing was pre-specified in the protocol. |
| Time Frame | Day 30-60 postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Implanted Analysis Set |
| Arm/Group Title | PanOptix Toric Trifocal IOL |
|---|---|
| Arm/Group Description | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Measure Participants | 32 |
| Measure eyes | 41 |
| Number [percentage of eyes] |
100
|
| Title | Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) |
|---|---|
| Description | 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. No confirmatory statistical hypothesis testing was pre-specified in the protocol. |
| Time Frame | Day 30-60 postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Implanted Analysis Set |
| Arm/Group Title | PanOptix Toric Trifocal IOL |
|---|---|
| Arm/Group Description | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Measure Participants | 32 |
| Measure eyes | 41 |
| Mean (Standard Deviation) [diopter] |
0.055
(0.153)
|
Adverse Events
| Time Frame | Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 30-60 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes. | |||||||
| Arm/Group Title | Pretreatment | TFNT20 Ocular / First Eye | TFNT20 Ocular / Second Eye | TFNT20 Nonocular / Systemic | ||||
| Arm/Group Description | Events reported in this group occurred prior to attempted implantation with the test article | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye | Events reported in this group occurred after attempted implantation with the test article | ||||
All Cause Mortality |
||||||||
| Pretreatment | TFNT20 Ocular / First Eye | TFNT20 Ocular / Second Eye | TFNT20 Nonocular / Systemic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | 0/32 (0%) | 0/9 (0%) | 0/32 (0%) | ||||
Serious Adverse Events |
||||||||
| Pretreatment | TFNT20 Ocular / First Eye | TFNT20 Ocular / Second Eye | TFNT20 Nonocular / Systemic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | 0/32 (0%) | 0/9 (0%) | 0/32 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Pretreatment | TFNT20 Ocular / First Eye | TFNT20 Ocular / Second Eye | TFNT20 Nonocular / Systemic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | 5/32 (15.6%) | 1/9 (11.1%) | 0/32 (0%) | ||||
| Investigations | ||||||||
| Intraocular pressure increased | 0/32 (0%) | 5/32 (15.6%) | 1/9 (11.1%) | 0/32 (0%) | ||||
Limitations/Caveats
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 | Director of Clinical Projects, Surgical |
|---|---|
| Organization | Alcon Research, LLC |
| Phone | +1-817-909-6199 |
| jessie.hull@alcon.com |
- ILX140-C001