Trial Outcomes & Findings for Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia (NCT NCT01166568)
NCT ID: NCT01166568
Last Updated: 2018-09-28
Results Overview
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.
COMPLETED
NA
337 participants
From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
2018-09-28
Participant Flow
The prospective, multicenter clinical trial of the PresView Implant was conducted at 14 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 |
PresVIEW Implantation - Non-Randomized
Subjects in the non-randomized arm of the study were bilaterally implanted and followed for 24 months. Per the protocol, primary endpoint analysis was performed on the primary eye (only). Fellow eyes were followed for safety and summarized separately
|
PresVIEW Implantation - Randomized
A randomized sub-study was used to evaluate the early (6 Month) effectiveness of the PresVIEW™ Scleral Implants against a deferred control group (no treatment). Subjects in the randomized sub-study that were randomly assigned to the immediate treatment (surgical) group were bilaterally implanted and followed for 24 months. Pre-operative, 3 month and 6 month post-operative visual acuity for the primary eye was compared to the differed treatment group primary eye visual acuity results. Thirty-two subjects of the total 48 subjects participating in the randomized sub-study, were randomly assigned to receive immediate surgery.
|
PresVIEW Deferred Implantation - Randomized
Subjects in the randomized sub-study that were randomly assigned to the deferred treatment (control) group were bilaterally implanted after 6 months observation and followed for 24 months post-op. Sixteen subjects of the total 48 subjects participating in the randomized sub-study were randomly assigned to the control group and followed for 6 months prior to surgery (observation). These patients will provide additional informed consent for implantation and their results will be included in the total patient cohort for the PSI SGP-046. Total study participation will be either 6 months (if they did not elect treatment after 6 months observation), or 30 months (6 months observation + 24 months post-operative) if they elected treatment. The observation period included follow-up visits for Day 0 (baseline), 3 months, and 6 months for the randomized sub-study and visual acuity for the primary eye was compared to the immediate treatment group primary eye visual acuity for analysis.
|
|---|---|---|---|
|
Deferred Implantation- Randomized
STARTED
|
0 0
|
0 0
|
16 32
|
|
Deferred Implantation- Randomized
COMPLETED
|
0 0
|
0 0
|
15 30
|
|
Deferred Implantation- Randomized
NOT COMPLETED
|
0 0
|
0 0
|
1 2
|
|
Implantation- Nonrandomized & Randomized
STARTED
|
288 562
|
33 66
|
9 17
|
|
Implantation- Nonrandomized & Randomized
COMPLETED
|
274 537
|
32 64
|
8 16
|
|
Implantation- Nonrandomized & Randomized
NOT COMPLETED
|
14 25
|
1 2
|
1 1
|
Reasons for withdrawal
| Measure |
PresVIEW Implantation - Non-Randomized
Subjects in the non-randomized arm of the study were bilaterally implanted and followed for 24 months. Per the protocol, primary endpoint analysis was performed on the primary eye (only). Fellow eyes were followed for safety and summarized separately
|
PresVIEW Implantation - Randomized
A randomized sub-study was used to evaluate the early (6 Month) effectiveness of the PresVIEW™ Scleral Implants against a deferred control group (no treatment). Subjects in the randomized sub-study that were randomly assigned to the immediate treatment (surgical) group were bilaterally implanted and followed for 24 months. Pre-operative, 3 month and 6 month post-operative visual acuity for the primary eye was compared to the differed treatment group primary eye visual acuity results. Thirty-two subjects of the total 48 subjects participating in the randomized sub-study, were randomly assigned to receive immediate surgery.
|
PresVIEW Deferred Implantation - Randomized
Subjects in the randomized sub-study that were randomly assigned to the deferred treatment (control) group were bilaterally implanted after 6 months observation and followed for 24 months post-op. Sixteen subjects of the total 48 subjects participating in the randomized sub-study were randomly assigned to the control group and followed for 6 months prior to surgery (observation). These patients will provide additional informed consent for implantation and their results will be included in the total patient cohort for the PSI SGP-046. Total study participation will be either 6 months (if they did not elect treatment after 6 months observation), or 30 months (6 months observation + 24 months post-operative) if they elected treatment. The observation period included follow-up visits for Day 0 (baseline), 3 months, and 6 months for the randomized sub-study and visual acuity for the primary eye was compared to the immediate treatment group primary eye visual acuity for analysis.
|
|---|---|---|---|
|
Deferred Implantation- Randomized
Withdrawal by Subject
|
0
|
0
|
1
|
|
Implantation- Nonrandomized & Randomized
Lost to Follow-up
|
7
|
1
|
0
|
|
Implantation- Nonrandomized & Randomized
Withdrawal by Subject
|
7
|
0
|
1
|
Baseline Characteristics
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Baseline characteristics by cohort
| Measure |
PresVIEW Implantation Non-Randomized
n=288 Participants
288 subjects that received the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months. This sample consists of; 16 randomized deferred implantation subjects, 32 randomized implantation subjects, and 282 non-randomized implanted subjects (i.e. all enrolled subjects).
|
PresVIEW Implantation - Randomized
n=33 Participants
33 randomized subjects entered into a immediate treatment (implantation) group. Subjects were followed for 24 months. Immediate treatment group data was compared to the Deferred Treatment group at 6 months.
|
PresVIEW Deferred Implantation - Randomized
n=16 Participants
16 randomized subjects entered into a deferred treatment (control) group arm. Subjects were followed for 6 months (observation). Subjects that completed the 6 month observation were then offered PresVIEW implantation.
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.92 Years
STANDARD_DEVIATION 2.90 • n=5 Participants
|
54.62 Years
STANDARD_DEVIATION 2.96 • n=7 Participants
|
55.03 Years
STANDARD_DEVIATION 2.66 • n=5 Participants
|
54.93 Years
STANDARD_DEVIATION 2.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
256 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
258 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
288 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
337 Participants
n=4 Participants
|
|
DCNVA 20/40 or Better (at baseline)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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 or improvement of 2 or more lines at 24 months for the primary eye.
Outcome measures
| Measure |
Overall Study Population
n=317 Primary Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
|
288 Primary Eyes
|
SECONDARY outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis. The point estimates were calculated for each of the following events at 24 months. Only the incidence of serious adverse events (SAE's) is presented here as only (1) secondary outcome is allowed.
The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Presence of Significant Safety Events (SAEs).
|
3 Primary and Fellow Eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis.
All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Safety Parameter Point Estimate -- Anterior Segment Ischemia
|
0 Primary and Fellow Eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis.
All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA \> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines
|
1 Primary and Fellow Eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis.
All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA \> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines
|
0 Primary and Fellow Eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis.
All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase \> 10 mmHg) or (IOP \> 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)
|
55 Primary and Fellow Eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis.
All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Safety Parameter Point Estimate -- Chronic Inflammation
|
4 Primary and Fellow Eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.Population: All subject eyes implanted with the PSI were included in the safety analysis.
All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase \>= 0.20) AND (Myopic Shift \> 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Outcome measures
| Measure |
Overall Study Population
n=645 Primary and Fellow Eyes
A total of 330 subjects at 11 sites received implantation of the PSI 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 PSI.
|
|---|---|
|
Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)
|
0 Primary and Fellow Eyes
|
Adverse Events
PresVIEW Implantation - Single Arm
Serious adverse events
| Measure |
PresVIEW Implantation - Single Arm
n=330 participants at risk
330 nonrandomized subjects entered into a single group arm to receive the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months.
|
|---|---|
|
Eye disorders
Decreased iris perfusion
|
0.91%
3/330 • Number of events 3 • Adverse event reporting continued through 24 months.
|
Other adverse events
| Measure |
PresVIEW Implantation - Single Arm
n=330 participants at risk
330 nonrandomized subjects entered into a single group arm to receive the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months.
|
|---|---|
|
Eye disorders
Anterior Eye Structural Change, Deposit and Degeneration
|
6.4%
21/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Eye Disorders NEC
|
14.2%
47/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Ocular Hemorrhages and Vascular Disorders NEC
|
3.3%
11/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Ocular Infections, Irritations and Inflammations
|
21.2%
70/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Ocular Neoplasms
|
2.1%
7/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Ocular Neuromuscular Disorders
|
1.2%
4/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Ocular Sensory Symptoms NEC
|
2.4%
8/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Ocular Structural Change, Deposit and Degeneration NEC
|
2.7%
9/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Retina, Choroid and Vitreous Hemorrhages and Vascular Disorders
|
1.5%
5/330 • Adverse event reporting continued through 24 months.
|
|
Eye disorders
Vision Disorders
|
0.30%
1/330 • Adverse event reporting continued through 24 months.
|
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 efficacy 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