Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00747565
• Collaborator: (none)
• Enrollment: 470
• Arms: 2
• Duration (Months): 48

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Tecnis ZM900 Multifocal Intraocular Lens; Device: CeeOn 911A monofocal IOL	N/A

Detailed Description

The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 470 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tecnis Multifocal IOL group Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.	Device: Tecnis ZM900 Multifocal Intraocular Lens; Investigational intraocular lens
Active Comparator: CeeOn 911A monofocal control IOL group Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.	Device: CeeOn 911A monofocal IOL; Monofocal Control IOL

Outcome Measures

Primary Outcome Measures

1. Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. [One year]

   Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.

2. Mean Binocular Distance Corrected Near Visual Acuity in Snellen [One year]

   Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Visual potential of 20/30 or better in each study eye

• Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)

• Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye

• Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria:

• Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)

• Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)

• Uncontrolled systemic or ocular disease

• History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention

• Presence of ocular pathology other than cataract such as:

• Amblyopia or strabismus

• Corneal abnormalities

• Pupil abnormalities

• Capsule or zonule abnormalities

• Intraocular inflammation

• Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)

• Requiring an intraocular lens outside the study diopter range

• Contact lens usage prior to study procedure (time interval dependent upon contact lens type)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Principal Investigator: Mark Packer, M.D., Drs. Fine, Hoffman and Packer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT00747565
• Other Study ID Numbers: DIOL-104-TCNS & DIOL-101-TCNS
• First Posted: Sep 5, 2008
• Last Update Posted: Mar 4, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Abbott Medical Optics: cataract, tecnis, multifocal, intraocular lens
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Multifocal and monofocal control subjects were enrolled in the original study in 2004-2005 from the normal cataract populations at 13 USA sites. In the expansion study, additional multifocal subjects were enrolled from the normal cataract populations at 16 USA sites (13 who also participated in the original study) in 2007.
Pre-assignment Detail	Subjects chose which type of lens to receive (multifocal or monofocal) in the original study. Subjects only received the multifocal lens in the expansion study.

Arm/Group Title	Tecnis Multifocal Subjects	Monofocal Control Subjects
Arm/Group Description	Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Period Title: Overall Study
STARTED	347	123
COMPLETED	333	116
NOT COMPLETED	14	7

Baseline Characteristics

Arm/Group Title	Tecnis Multifocal Subjects	Monofocal Control Subjects	Total
Arm/Group Description	Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.	Total of all reporting groups
Overall Participants	347	123	470
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	144 41.5%	27 22%	171 36.4%
>=65 years	203 58.5%	96 78%	299 63.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (9.5)	68.7 (8.9)	66.7 (9.4)
Sex: Female, Male (Count of Participants)
Female	211 60.8%	81 65.9%	292 62.1%
Male	136 39.2%	42 34.1%	178 37.9%
Region of Enrollment (participants) [Number]
United States	347 100%	123 100%	470 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
Description	Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

First eye results from subjects at one year in both the original study and the expansion study combined.

Arm/Group Title	Tecnis Multifocal Subjects	Monofocal Control Subjects
Arm/Group Description	Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Measure Participants	331	114
Number [Participants (First Eyes only)]	329 94.8%	114 92.7%

2. Primary Outcome

Title	Mean Binocular Distance Corrected Near Visual Acuity in Snellen
Description	Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Binocular subjects at one year available for testing for both studies combined.

Arm/Group Title	Tecnis Multifocal Subjects	Monofocal Control Subjects
Arm/Group Description	Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Measure Participants	291	113
Mean (Standard Deviation) [Mean Snellen Line (with ETDRS line SD)]	24 (1.09)	70 (1.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tecnis Multifocal Subjects, Monofocal Control Subjects
	Comments	ETDRS line scores used for statistical comparisons with mean Snellen values reported above.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Tecnis Multifocal Subjects		Monofocal Control Subjects
Arm/Group Description	Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.		Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
All Cause Mortality
	Tecnis Multifocal Subjects		Monofocal Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tecnis Multifocal Subjects		Monofocal Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/348 (4%)		1/123 (0.8%)
Eye disorders
Endophthalmitis, hypopyon and surgical intervention	1/348 (0.3%)	5	0/123 (0%)	0
Signifcant loss in vision due to stroke	1/348 (0.3%)	1	0/123 (0%)	0
Lens-related lens removal	1/348 (0.3%)	1	0/123 (0%)	0
Lens-related other surgical procedures	1/348 (0.3%)	1	0/123 (0%)	0
Non-lens-related lens exchange	4/348 (1.1%)	4	0/123 (0%)	0
Non-lens-related other surgical procedures	6/348 (1.7%)	6	1/123 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Tecnis Multifocal Subjects		Monofocal Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/348 (0%)		0/123 (0%)

Limitations/Caveats

Results from the original study (DIOL-101-TCNS) and the expansion study (DIOL-104-TCNS) were analyzed together. The original study enrolled both multifocal and monofocal control subjects; the expansion study enrolled additional multifocal subjects.

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.