Trial Outcomes & Findings for Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL) (NCT NCT01210807)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

4-6 Months

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens	ZCB00 Monofocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
Overall Study STARTED	36	34
Overall Study COMPLETED	33	31
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens	ZCB00 Monofocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
Overall Study Lost to Follow-up	1	2
Overall Study Not implanted bilaterally	2	1

Baseline Characteristics

Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZMB00 Multifocal Intraocular Lens n=34 Participants Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens	ZCB00 Monofocal Intraocular Lens n=33 Participants Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens	Total n=67 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	68.3 years STANDARD_DEVIATION 11.3 • n=7 Participants	65.9 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 Months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	ZMB00 Multifocal Intraocular Lens n=33 Participants Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens	ZCB00 Monofocal Intraocular Lens n=31 Participants Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm	0.07 logMAR visual acuity Standard Deviation 0.12	0.61 logMAR visual acuity Standard Deviation 0.15

SECONDARY outcome

Timeframe: 4-6 months

Population: 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.

Outcome measures

Outcome measures
Measure	ZMB00 Multifocal Intraocular Lens n=32 Participants Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens	ZCB00 Monofocal Intraocular Lens n=31 Participants Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity	32 participants	31 participants

Adverse Events

ZMB00 Multifocal Intraocular Lens

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ZCB00 Monofocal Intraocular Lens

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ZMB00 Multifocal Intraocular Lens n=36 participants at risk Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens	ZCB00 Monofocal Intraocular Lens n=34 participants at risk Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
Eye disorders Macular edema	2.8% 1/36 • Number of events 1	2.9% 1/34 • Number of events 1
Eye disorders Vitreous detachment	2.8% 1/36 • Number of events 1	0.00% 0/34
Eye disorders IOL replacement secondary to broken haptic during surgery	0.00% 0/36	2.9% 1/34 • Number of events 1
Eye disorders Wound leakage	0.00% 0/36	2.9% 1/34 • Number of events 1
Injury, poisoning and procedural complications Head injury secondary to car accident	2.8% 1/36 • Number of events 1	0.00% 0/34
Injury, poisoning and procedural complications Head and shoulder injury secondary to wheelchair malfunction	0.00% 0/36	2.9% 1/34 • Number of events 1

Additional Information

PD Dr. med. Peter Szurman

University Eye Clinic, Tubingen, Germany

Phone: 49-7071-29-84915

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER