Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Multifocal Intraocular Lens ZMB00 multifocal intraocular lens |
Device: One-Piece Tecnis Multifocal IOL
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Other Names:
|
Active Comparator: Monofocal Intraocular Lens ZCB00 monofocal intraocular lens |
Device: One-Piece Tecnis monofocal IOL, Model ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm [4-6 Months]
Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.
Secondary Outcome Measures
- Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity [4-6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
bilateral cataracts and otherwise healthy eyes
-
visual potential of Decimal 0.8 in each eye
Exclusion Criteria:
-
any medications affecting vision
-
any chronic disease/illness that would affect risk to subject or outcomes of the study
-
any ocular pathology/abnormalities that may affect visual outcomes or confound study results
-
desire for monovision
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Augenarzte Gemeinschaftspraxis Ahaus | Ahaus | Germany | 48683 | |
2 | University Eye Clinic | Heidelberg | Germany | 69120 | |
3 | Klinikum Ernst von Bergmann gGmbH | Potsdam | Germany | 14467 | |
4 | University Eye Clinic | Tubingen | Germany | 72076 |
Sponsors and Collaborators
- Abbott Medical Optics
Investigators
- Principal Investigator: Peter Szurman, PD Dr. med.,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIOL-105-TMF1
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
---|---|---|
Arm/Group Description | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens |
Period Title: Overall Study | ||
STARTED | 36 | 34 |
COMPLETED | 33 | 31 |
NOT COMPLETED | 3 | 3 |
Baseline Characteristics
Arm/Group Title | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | Total |
---|---|---|---|
Arm/Group Description | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens | Total of all reporting groups |
Overall Participants | 34 | 33 | 67 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
63.1
(11.4)
|
68.3
(11.3)
|
65.9
(11.6)
|
Sex: Female, Male (Count of Participants) | |||
Female |
23
67.6%
|
17
51.5%
|
40
59.7%
|
Male |
11
32.4%
|
16
48.5%
|
27
40.3%
|
Outcome Measures
Title | Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity |
---|---|
Description | |
Time Frame | 4-6 months |
Outcome Measure Data
Analysis Population Description |
---|
Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit. |
Arm/Group Title | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
---|---|---|
Arm/Group Description | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens |
Measure Participants | 32 | 31 |
Number [participants] |
32
94.1%
|
31
93.9%
|
Title | Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm |
---|---|
Description | Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group. |
Time Frame | 4-6 Months |
Outcome Measure Data
Analysis Population Description |
---|
Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit. |
Arm/Group Title | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
---|---|---|
Arm/Group Description | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens |
Measure Participants | 33 | 31 |
Mean (Standard Deviation) [logMAR visual acuity] |
0.07
(0.12)
|
0.61
(0.15)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | ||
Arm/Group Description | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens | ||
All Cause Mortality |
||||
ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/36 (0%) | 0/34 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/36 (8.3%) | 4/34 (11.8%) | ||
Eye disorders | ||||
Macular edema | 1/36 (2.8%) | 1 | 1/34 (2.9%) | 1 |
Vitreous detachment | 1/36 (2.8%) | 1 | 0/34 (0%) | 0 |
IOL replacement secondary to broken haptic during surgery | 0/36 (0%) | 0 | 1/34 (2.9%) | 1 |
Wound leakage | 0/36 (0%) | 0 | 1/34 (2.9%) | 1 |
Injury, poisoning and procedural complications | ||||
Head injury secondary to car accident | 1/36 (2.8%) | 1 | 0/34 (0%) | 0 |
Head and shoulder injury secondary to wheelchair malfunction | 0/36 (0%) | 0 | 1/34 (2.9%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | PD Dr. med. Peter Szurman |
---|---|
Organization | University Eye Clinic, Tubingen, Germany |
Phone | 49-7071-29-84915 |
peter.szurman@med.uni-tuebingen.de |
- DIOL-105-TMF1