Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ZV9003 modified light transmission intraocular lens |
Device: modified light transmission intraocular lens
violet visible light blocking acrylic intraocular lens
Other Names:
|
| Active Comparator: ZA9003 monofocal acrylic intraocular lens |
Device: monofocal acrylic intraocular lens
conventional hydrophobic acrylic intraocular lens
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Best Corrected Distance Visual Acuity [One year]
Snellen Equivalent visual acuity of 20/40 or better
- Uncorrected Distance Visual Acuity [One Year]
Snellen Equivalent of 20/40 or better at one year
Secondary Outcome Measures
- Contrast Sensitivity [4-6 months]
Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
- Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". [One Year]
Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 years of age or older
-
Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
-
Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
-
Preoperative corneal astigmatism of 1.5 diopters or less
Exclusion Criteria:
-
Use of systemic or ocular medications that may affect vision
-
Uncontrolled systemic or recurrent ocular disease
-
Requiring an intraocular lens <15.0 or >26.0 diopters
-
Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
-
History of ocular trauma or prior ocular surgery
-
Known pathology that may affect visual acuity or visual field
-
Corneal abnormalities
-
Pupil abnormalities
-
Capsule or zonular abnormalities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Patrick Aiello, M.D. | Scottsdale | Arizona | United States | 85054 |
| 2 | Randall E. Cole, M.D. | Rogers | Arkansas | United States | 72756 |
| 3 | Aron Rose, M.D. | New Haven | Connecticut | United States | 06510 |
| 4 | Y. Ralph Chu, M.D. | Bloomington | Minnesota | United States | 55420 |
| 5 | Steven Silverstein, M.D. | Kansas City | Missouri | United States | 64133 |
| 6 | Jon-Marc Weston, M.D. | Roseburg | Oregon | United States | 97470 |
| 7 | William Christie, M.D. | Cranberry Township | Pennsylvania | United States | 16066 |
| 8 | Mark Blecher, M.D. | Philadelphia | Pennsylvania | United States | 19148 |
| 9 | Robert L. Bahr, M.D. | Providence | Rhode Island | United States | 02906 |
| 10 | Vance Thompson, M.D. | Sioux Falls | South Dakota | United States | 57105 |
| 11 | Jay Rudd, M.D. | Lacey | Washington | United States | 98503 |
Sponsors and Collaborators
- Abbott Medical Optics
Investigators
- Principal Investigator: Roger F. Steinert, M.D., University of California, Irvine, Dept. of Ophthalmology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BBLK-102-PRSM
Study Results
Participant Flow
| Recruitment Details | 250 subjects from normal cataract populations who were undergoing primary phacoemulsification with lens implantation and did not have any other visually significant ocular pathologies were selected at 12 investigation sites across the country |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens |
|---|---|---|
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens |
| Period Title: Overall Study | ||
| STARTED | 126 | 124 |
| COMPLETED | 120 | 120 |
| NOT COMPLETED | 6 | 4 |
Baseline Characteristics
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens | Total |
|---|---|---|---|
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens | Total of all reporting groups |
| Overall Participants | 126 | 124 | 250 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
73.3
(8.0)
|
71.5
(8.0)
|
72.4
(8.0)
|
| Age, Customized (participants) [Number] | |||
| <60 years |
4
3.2%
|
8
6.5%
|
12
4.8%
|
| Between 60 and 69 years |
35
27.8%
|
41
33.1%
|
76
30.4%
|
| Between 70 and 79 years |
57
45.2%
|
54
43.5%
|
111
44.4%
|
| >=80 |
30
23.8%
|
21
16.9%
|
51
20.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
78
61.9%
|
68
54.8%
|
146
58.4%
|
| Male |
48
38.1%
|
56
45.2%
|
104
41.6%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
126
100%
|
124
100%
|
250
100%
|
Outcome Measures
| Title | Best Corrected Distance Visual Acuity |
|---|---|
| Description | Snellen Equivalent visual acuity of 20/40 or better |
| Time Frame | One year |
Outcome Measure Data
| Analysis Population Description |
|---|
| One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes. |
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens |
|---|---|---|
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens |
| Measure Participants | 119 | 120 |
| Number [participants] |
119
94.4%
|
120
96.8%
|
| Title | Contrast Sensitivity |
|---|---|
| Description | Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. |
| Time Frame | 4-6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported. |
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens |
|---|---|---|
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens |
| Measure Participants | 120 | 120 |
| Mesopic condition at 3.0 cpd |
1.62
|
1.62
|
| Mesopic condition at 6.0 cpd |
1.65
|
1.63
|
| Mesopic condition at 12.0 cpd |
1.14
|
1.17
|
| Mesopic condition at 18.0 cpd |
0.60
|
0.65
|
| Photopic condition at 3.0 cpd |
1.76
|
1.74
|
| Photopic condition at 6.0 cpd |
1.91
|
1.94
|
| Photopic condition at 12.0 cpd |
1.58
|
1.59
|
| Photopic condition at 18.0 cpd |
1.09
|
1.14
|
| Title | Uncorrected Distance Visual Acuity |
|---|---|
| Description | Snellen Equivalent of 20/40 or better at one year |
| Time Frame | One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes. |
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens |
|---|---|---|
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens |
| Measure Participants | 119 | 120 |
| Number [participants] |
110
87.3%
|
116
93.5%
|
| Title | Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". |
|---|---|
| Description | Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit. |
| Time Frame | One Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two subjects in the ZV9003 group did not complete the one year questionnaire. |
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens |
|---|---|---|
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens |
| Measure Participants | 118 | 119 |
| Number [participants] |
112
88.9%
|
113
91.1%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens | ||
| Arm/Group Description | modified light transmission intraocular lens | monofocal acrylic intraocular lens | ||
All Cause Mortality |
||||
| ZV9003 Intraocular Lens | ZA9003 Intraocular Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| ZV9003 Intraocular Lens | ZA9003 Intraocular Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/126 (0.8%) | 1/124 (0.8%) | ||
| Eye disorders | ||||
| Retinal Tear requiring secondary surgical intervention | 1/126 (0.8%) | 1 | 1/124 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| ZV9003 Intraocular Lens | ZA9003 Intraocular Lens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/124 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PIs may not publish or disclose study data without Sponsor's prior written approval.
Results Point of Contact
| Name/Title | Nicholas Taranatino, O.D., Head, Global Clinical Research & Devlopment |
|---|---|
| Organization | Abbott medical Optics, Inc. |
| Phone | 866-427-8477 ext 8613 |
| nicholas.tarantino@amo.abbott.com |
- BBLK-102-PRSM