Trial Outcomes & Findings for A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients (NCT NCT01684007)

Last Updated: 2015-06-22

Results Overview

Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

Day 90 from second eye implantation

Results posted on

2015-06-22

Participant Flow

Subjects were recruited from 8 investigative sites located outside the USA, including Argentina (1), Chile (1), Germany (2), Netherlands (2), and Spain (2).

Of the 112 subjects enrolled, 9 were discontinued prior to randomization as screen failures. This reporting group includes all implanted subjects (103).

Participant milestones

Participant milestones
Measure	Bilateral AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation	Contralateral AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
Overall Study STARTED	53	50
Overall Study COMPLETED	53	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral n=53 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation	Contralateral n=50 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation	Total n=103 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 7.9 • n=5 Participants	65.9 years STANDARD_DEVIATION 10.1 • n=7 Participants	66.6 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Germany	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Spain	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Argentina	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Chile	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 90 from second eye implantation

Population: This analysis population includes all subjects with both eyes implanted.

Outcome measures

Outcome measures
Measure	Bilateral n=53 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation	Contralateral n=50 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)	0.13 logMAR Standard Deviation 0.148	0.09 logMAR Standard Deviation 0.133

SECONDARY outcome

Timeframe: Day 90 from second eye implantation

Population: This analysis population includes all subjects with both eyes implanted.

VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

Outcome measures

Outcome measures
Measure	Bilateral n=53 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation	Contralateral n=50 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)	0.26 logMAR Standard Deviation 0.158	0.10 logMAR Standard Deviation 0.134

Adverse Events

Bilateral

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Contralateral

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bilateral n=53 participants at risk AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation	Contralateral n=50 participants at risk AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
Ear and labyrinth disorders Vertigo	0.00% 0/53 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.	2.0% 1/50 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
Metabolism and nutrition disorders Dehydration	0.00% 0/53 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.	2.0% 1/50 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.

Other adverse events

Other adverse events
Measure	Bilateral n=53 participants at risk AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation	Contralateral n=50 participants at risk AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
Musculoskeletal and connective tissue disorders Sjogren's syndrome	5.7% 3/53 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.	6.0% 3/50 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.

Additional Information

Magda Michna, Expert Clinical Lead, Surgical

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER