Trial Outcomes & Findings for Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses (NCT NCT02176343)
NCT ID: NCT02176343
Last Updated: 2018-07-02
Results Overview
Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder \[defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder\], multiplied by 100%. One eye (primary eye) contributed to the analysis.
COMPLETED
NA
37 participants
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
2018-07-02
Participant Flow
Subjects were recruited from 4 study centers located in Australia.
Of the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).
Participant milestones
| Measure |
ReSTOR Toric +2.5
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
Baseline characteristics by cohort
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder \[defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder\], multiplied by 100%. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Mean Percent Reduction in Cylinder
|
60.94 percent change
Standard Deviation 38.17
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
|
67.7 percentage of subjects
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism \> 1.00 D.
Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=12 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
|
100.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Mean Uncorrected Distance Visual Acuity
|
0.07 logMAR
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Mean Uncorrected Near Visual Acuity
|
0.38 logMAR
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Mean Uncorrected Intermediate Visual Acuity
|
0.25 logMAR
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Mean Best Corrected Distance Visual Acuity (BCDVA)
|
-0.03 logMAR
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)Population: As Treated
Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.
Outcome measures
| Measure |
ReSTOR Toric +2.5
n=31 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Mean IOL Rotation
|
3.74 degrees
Standard Deviation 3.86
|
Adverse Events
ReSTOR Toric +2.5
Serious adverse events
| Measure |
ReSTOR Toric +2.5
n=31 participants at risk
All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Eye disorders
Macular oedema
|
3.2%
1/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
|
Eye disorders
Retinal vein occlusion
|
3.2%
1/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
|
Eye disorders
Strabismus
|
3.2%
1/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
|
Infections and infestations
Staphylococcal infection
|
3.2%
1/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Intra-ocular injection
|
3.2%
1/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
ReSTOR Toric +2.5
n=31 participants at risk
All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|---|---|
|
Eye disorders
Photopsia
|
6.5%
2/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Knee arthroplasty
|
6.5%
2/31 • The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
|
Additional Information
Clinical Project Lead, GCRA, Surgical
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER