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Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia

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ClinicalTrials.gov Identifier: NCT01166568
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Refocus Group, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Presbyopia
Intervention Device: PresVIEW Scleral Implants
Enrollment 337
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title PresVIEW Implantation - Non-Randomized PresVIEW Implantation - Randomized PresVIEW Deferred Implantation - Randomized
Hide Arm/Group Description 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 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. 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.
Period Title: Deferred Implantation- Randomized
Number of participants Number of units (Eye) Number of participants Number of units (Eye) Number of participants Number of units (Eye)
Started 0 0 0 0 16 32
Completed 0 0 0 0 15 [1] 30
Not Completed 0 0 0 0 1 2
Reason Not Completed
Withdrawal by Subject             0                         0                         1            
[1]
From the randomized sub-study control group (n=16), 1 subject withdrew during the observation phase
Period Title: Implantation- Nonrandomized & Randomized
Number of participants Number of units (Eye) Number of participants Number of units (Eye) Number of participants Number of units (Eye)
Started 288 562 33 66 9 [1] 17
Completed 274 537 32 64 8 [2] 16
Not Completed 14 25 1 2 1 1
Reason Not Completed
Lost to Follow-up             7                         1                         0            
Withdrawal by Subject             7                         0                         1            
[1]
15 subjects completed the observation phase and 9 subjects (17 eyes) proceeded with implantation.
[2]
(1) Primary eye implanted only subject withdrew consent after implantation of the device.
Arm/Group Title PresVIEW Implantation Non-Randomized PresVIEW Implantation - Randomized PresVIEW Deferred Implantation - Randomized Total
Hide Arm/Group Description 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). 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. 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 of all reporting groups
Overall Number of Baseline Participants 288 33 16 337
Hide Baseline Analysis Population Description
Between 50 to 60 years of age at the commencement of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 288 participants 33 participants 16 participants 337 participants
54.92  (2.90) 54.62  (2.96) 55.03  (2.66) 54.93  (2.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 33 participants 16 participants 337 participants
Female
128
  44.4%
15
  45.5%
8
  50.0%
151
  44.8%
Male
160
  55.6%
18
  54.5%
8
  50.0%
186
  55.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 33 participants 16 participants 337 participants
Hispanic or Latino
32
  11.1%
6
  18.2%
2
  12.5%
40
  11.9%
Not Hispanic or Latino
256
  88.9%
27
  81.8%
14
  87.5%
297
  88.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 33 participants 16 participants 337 participants
American Indian or Alaska Native
4
   1.4%
0
   0.0%
0
   0.0%
4
   1.2%
Asian
2
   0.7%
0
   0.0%
0
   0.0%
2
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
   4.2%
0
   0.0%
0
   0.0%
12
   3.6%
White
258
  89.6%
27
  81.8%
14
  87.5%
299
  88.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
   4.2%
6
  18.2%
2
  12.5%
20
   5.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 288 participants 33 participants 16 participants 337 participants
288
 100.0%
33
 100.0%
16
 100.0%
337
 100.0%
DCNVA 20/40 or Better (at baseline)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 33 participants 16 participants 337 participants
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.3%
1.Primary Outcome
Title Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
Hide Description 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.
Time Frame From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 317
Overall Number of Units Analyzed
Type of Units Analyzed: Primary Eyes
317
Count of Units
Unit of Measure: Primary Eyes
288
  90.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments

The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:

H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 > 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 > 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments the p-value is adjusted for multiple comparisons
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter binomial distribution
Estimated Value 0.75
Confidence Interval (1-Sided) 97.5%
0.75
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Presence of Significant Safety Events (SAEs).
Hide Description

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.

Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
3
   0.5%
3.Other Pre-specified Outcome
Title Safety Parameter Point Estimate -- Anterior Segment Ischemia
Hide Description 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.
Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject eyes implanted with the PSI were included in the safety analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
0
   0.0%
4.Other Pre-specified Outcome
Title Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines
Hide Description

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.

Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject eyes implanted with the PSI were included in the safety analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
1
   0.2%
5.Other Pre-specified Outcome
Title Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines
Hide Description

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.

Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject eyes implanted with the PSI were included in the safety analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
0
   0.0%
6.Other Pre-specified Outcome
Title Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)
Hide Description

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.

Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject eyes implanted with the PSI were included in the safety analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
55
   8.5%
7.Other Pre-specified Outcome
Title Safety Parameter Point Estimate -- Chronic Inflammation
Hide Description

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.

Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject eyes implanted with the PSI were included in the safety analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
4
   0.6%
8.Other Pre-specified Outcome
Title Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)
Hide Description

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.

Time Frame From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject eyes implanted with the PSI were included in the safety analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Overall Number of Participants Analyzed 330
Overall Number of Units Analyzed
Type of Units Analyzed: Primary and Fellow Eyes
645
Count of Units
Unit of Measure: Primary and Fellow Eyes
0
   0.0%
Time Frame Adverse event reporting continued through 24 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PresVIEW Implantation - Single Arm
Hide Arm/Group Description 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.
All-Cause Mortality
PresVIEW Implantation - Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PresVIEW Implantation - Single Arm
Affected / at Risk (%) # Events
Total   3/330 (0.91%)    
Eye disorders   
Decreased iris perfusion * 1  3/330 (0.91%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PresVIEW Implantation - Single Arm
Affected / at Risk (%) # Events
Total   143/330 (43.33%)    
Eye disorders   
Anterior Eye Structural Change, Deposit and Degeneration  1  21/330 (6.36%) 
Eye Disorders NEC  1  47/330 (14.24%) 
Ocular Hemorrhages and Vascular Disorders NEC  1  11/330 (3.33%) 
Ocular Infections, Irritations and Inflammations  1  70/330 (21.21%) 
Ocular Neoplasms  1  7/330 (2.12%) 
Ocular Neuromuscular Disorders  1  4/330 (1.21%) 
Ocular Sensory Symptoms NEC  1  8/330 (2.42%) 
Ocular Structural Change, Deposit and Degeneration NEC  1  9/330 (2.73%) 
Retina, Choroid and Vitreous Hemorrhages and Vascular Disorders  1  5/330 (1.52%) 
Vision Disorders  1  1/330 (0.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Name/Title: Director of Regulatory & Quality
Organization: Refocus Group, Inc.
Phone: 214-368-0200 ext 431
Responsible Party: Refocus Group, Inc.
ClinicalTrials.gov Identifier: NCT01166568     History of Changes
Other Study ID Numbers: P-277-5
First Submitted: July 16, 2010
First Posted: July 21, 2010
Results First Submitted: January 9, 2017
Results First Posted: September 28, 2018
Last Update Posted: September 28, 2018