Trial Outcomes & Findings for A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients (NCT NCT02374671)
NCT ID: NCT02374671
Last Updated: 2020-01-06
Results Overview
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better and Gain of At Least 10 Letters at 24 months for the primary eye.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
365 participants
Primary outcome timeframe
From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Results posted on
2020-01-06
Participant Flow
The prospective, multicenter clinical trial of the VisAbility micro insert was conducted at 13 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.
Once determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.
Unit of analysis: Eye
Participant milestones
| Measure |
Implantation-Non-Randomzied
Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
Implantation-Randomized
Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
Deferred Implantion-Randomized
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
|
|---|---|---|---|
|
Observation (Deferred Implantation)
STARTED
|
0 0
|
0 0
|
31 62
|
|
Observation (Deferred Implantation)
COMPLETED
|
0 0
|
0 0
|
26 52
|
|
Observation (Deferred Implantation)
NOT COMPLETED
|
0 0
|
0 0
|
5 10
|
|
Implantation- Nonrandomized & Randomized
STARTED
|
306 604
|
28 55
|
26 49
|
|
Implantation- Nonrandomized & Randomized
COMPLETED
|
281 571
|
27 53
|
23 44
|
|
Implantation- Nonrandomized & Randomized
NOT COMPLETED
|
25 33
|
1 2
|
3 5
|
Reasons for withdrawal
| Measure |
Implantation-Non-Randomzied
Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
Implantation-Randomized
Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
Deferred Implantion-Randomized
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
|
|---|---|---|---|
|
Observation (Deferred Implantation)
Withdrawal by Subject
|
0
|
0
|
4
|
|
Observation (Deferred Implantation)
Adverse Event
|
0
|
0
|
1
|
|
Implantation- Nonrandomized & Randomized
Lost to Follow-up
|
17
|
1
|
2
|
|
Implantation- Nonrandomized & Randomized
Adverse Event
|
7
|
0
|
1
|
|
Implantation- Nonrandomized & Randomized
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients
Baseline characteristics by cohort
| Measure |
Implantation-Non-Randomized
n=306 Participants
Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
Implantation-Randomized
n=28 Participants
Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
Deferred Implantion-Randomized
n=26 Participants
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.8 years
n=93 Participants
|
50.1 years
n=4 Participants
|
51.0 years
n=27 Participants
|
51.6 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
143 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
217 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
283 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
319 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
262 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
307 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
306 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
360 Participants
n=483 Participants
|
|
DCNVA 20/40 or Better (at baseline)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.Population: Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better and Gain of At Least 10 Letters at 24 months for the primary eye.
Outcome measures
| Measure |
Overall Study Population
n=344 Participants
A total of 360 subjects at 14 sites received implantation of VisiAbility micro inserts and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the micro inserts.
|
Deferred Implantion-Randomized
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
|
|---|---|---|
|
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters.
|
289 Participants
|
—
|
SECONDARY outcome
Timeframe: From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.The randomized surgery group is defined as successful if the percentage of primary eyes achieving Distance Corrected Near Visual Acuity at 40 centimeters of 20/40 of Better and Gain of 10 Letters more at 6 months postoperative (i.e. 6-month responder rate) is higher than the percentage in the randomized control group.
Outcome measures
| Measure |
Overall Study Population
n=28 Participants
A total of 360 subjects at 14 sites received implantation of VisiAbility micro inserts and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the micro inserts.
|
Deferred Implantion-Randomized
n=29 Participants
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
|
|---|---|---|
|
Number of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy
|
18 Participants
|
2 Participants
|
Adverse Events
VisAbility Micro Insert Implantation - Single Arm
Serious events: 4 serious events
Other events: 170 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VisAbility Micro Insert Implantation - Single Arm
n=360 participants at risk
For post-implant safety analysis, the Implantation-Non Randomized, Implantation-Randomized, and Deferred Implantation-Randomized arms were combined into (one) safety cohort (306 subjects + 26 subjects + 28 subjects, respectively), per protocol. All 360 implanted subjects that received the VisAbility Micro Insert implantation were followed for 24 months and were not analyzed separately. I.e. Subjects who participated in the randomized sub-study crossed over into a single (safety) arm at the time of implantation. For safety analysis and adverse event reporting, all implanted subjects were considered one cohort as there was no difference in treatment nor follow-up after VisAbility Micro Insert implantation.
|
|---|---|
|
Eye disorders
Serious Ocular Adverse Events
|
0.00%
0/360 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
General disorders
Serious Non-Ocular Adverse Events
|
1.1%
4/360 • Number of events 4 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
Other adverse events
| Measure |
VisAbility Micro Insert Implantation - Single Arm
n=360 participants at risk
For post-implant safety analysis, the Implantation-Non Randomized, Implantation-Randomized, and Deferred Implantation-Randomized arms were combined into (one) safety cohort (306 subjects + 26 subjects + 28 subjects, respectively), per protocol. All 360 implanted subjects that received the VisAbility Micro Insert implantation were followed for 24 months and were not analyzed separately. I.e. Subjects who participated in the randomized sub-study crossed over into a single (safety) arm at the time of implantation. For safety analysis and adverse event reporting, all implanted subjects were considered one cohort as there was no difference in treatment nor follow-up after VisAbility Micro Insert implantation.
|
|---|---|
|
Eye disorders
Visual Acuity
|
2.5%
9/360 • Number of events 10 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Lid
|
9.2%
33/360 • Number of events 64 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Cornea/Conjunctiva
|
24.7%
89/360 • Number of events 159 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Iris/Pupil
|
0.28%
1/360 • Number of events 1 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Anterior Chamber
|
2.2%
8/360 • Number of events 9 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Lens
|
0.56%
2/360 • Number of events 3 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Sclera (Intraoperative Events)
|
2.2%
8/360 • Number of events 8 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Intraocular Pressure
|
1.7%
6/360 • Number of events 6 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Fundus/Posterior Pole
|
0.83%
3/360 • Number of events 3 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Surgical and medical procedures
Secondary Surgical Intervention
|
6.4%
23/360 • Number of events 28 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Surgical and medical procedures
Allergic Reactions to Medications
|
0.56%
2/360 • Number of events 4 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
|
Eye disorders
Other
|
13.9%
50/360 • Number of events 70 • Adverse event reporting continued through 24 months.
An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. The Sponsor encourages publication and presentation of the safety and effectiveness results upon completion of the study. Per the established agreement, the Principal Investigators will work with the Sponsor, in good faith, to ensure all confidential and proprietary information is redacted.
- Publication restrictions are in place
Restriction type: OTHER