A Phase 4 interventional study of One-Piece Tecnis Multifocal IOL and One-Piece Tecnis monofocal IOL, Model ZCB00 in Cataract, sponsored by Abbott Medical Optics. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Abbott Medical Optics (formerly part of Abbott) · Phase 4, Interventional, and Treatment
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.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 1,171 interventional studies indexed under Cataract.
Browse Cataract studies →Abbott Medical Optics is the lead sponsor of 35 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
First submitted before Abbott Medical Optics left Abbott.
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Exclusion Criteria:
ZMB00 multifocal intraocular lens
Device: One-Piece Tecnis Multifocal IOL
ZCB00 monofocal intraocular lens
Device: One-Piece Tecnis monofocal IOL, Model ZCB00
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Also known as: Model ZMB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Also known as: ZCB00
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
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
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
Time frame: 4-6 months
| Milestone | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
|---|---|---|
| Started | 36 | 34 |
| Completed | 33 | 31 |
| Not completed | 3 | 3 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Not implanted bilaterally | 2 | 1 |
| participants | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
|---|---|---|
| Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity | 32 | 31 |
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.
| logMAR visual acuity | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
|---|---|---|
| Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | 0.07 ± 0.12 | 0.61 ± 0.15 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZMB00 Multifocal Intraocular Lens | — | 0/36 (0%) | 3/36 (8.3%) |
| ZCB00 Monofocal Intraocular Lens | — | 0/34 (0%) | 4/34 (11.8%) |
| Event | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens |
|---|---|---|
| Macular edemaEye disorders | 1/36 | 1/34 |
| IOL replacement secondary to broken haptic during surgeryEye disorders | 0/36 | 1/34 |
| Wound leakageEye disorders | 0/36 | 1/34 |
| Head and shoulder injury secondary to wheelchair malfunctionInjury, poisoning and procedural complications | 0/36 | 1/34 |
| Vitreous detachmentEye disorders | 1/36 | 0/34 |
| Head injury secondary to car accidentInjury, poisoning and procedural complications | 1/36 | 0/34 |
A total of 34 ZMB00 multifocal and 33 ZCB00 monofocal subjects were implanted bilaterally. Data analysis for baseline characteristics was completed on these 67 subjects.
| Age, Continuous(years) | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | Total |
|---|---|---|---|
| Mean | 63.1 ± 11.4 | 68.3 ± 11.3 | 65.9 ± 11.6 |
| Sex: Female, Male(Participants) | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | Total |
|---|---|---|---|
| Female | 23 | 17 | 40 |
| Male | 11 | 16 | 27 |
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