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Trial Outcomes & Findings for Presbyopia-Correcting Intraocular Lenses (IOLs) (NCT NCT00963560)

NCT ID: NCT00963560

Last Updated: 2011-08-09

Results Overview

Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

132 participants

Primary outcome timeframe

6 Months after surgery

Results posted on

2011-08-09

Participant Flow

Bilateral diagnosis of cataracts of subjects \>21 years of age.

During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure
ReSTOR +3
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Crystalens HD
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Crystalens AO
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Overall Study
STARTED
47
44
41
Overall Study
COMPLETED
44
41
41
Overall Study
NOT COMPLETED
3
3
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Presbyopia-Correcting Intraocular Lenses (IOLs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ReSTOR +3
n=47 Participants
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Crystalens HD
n=44 Participants
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Crystalens AO
n=41 Participants
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Total
n=132 Participants
Total of all reporting groups
Age Continuous
63.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
64 years
STANDARD_DEVIATION 7.8 • n=7 Participants
65.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
64.23 years
STANDARD_DEVIATION 8.23 • n=4 Participants
Sex: Female, Male
Female
28 Participants
n=5 Participants
25 Participants
n=7 Participants
26 Participants
n=5 Participants
79 Participants
n=4 Participants
Sex: Female, Male
Male
19 Participants
n=5 Participants
19 Participants
n=7 Participants
15 Participants
n=5 Participants
53 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 6 Months after surgery

Population: 2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.

Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

Outcome measures

Outcome measures
Measure
ReSTOR +3
n=42 Participants
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Crystalens HD
n=40 Participants
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Crystalens AO
n=41 Participants
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Best Corrected Visual Acuity
40 cm (near) Distance
0.057 logMAR
Standard Deviation 0.086
0.364 logMAR
Standard Deviation 0.183
0.420 logMAR
Standard Deviation 0.188
Best Corrected Visual Acuity
4m (far) Distance
-0.075 logMAR
Standard Deviation 0.100
-0.080 logMAR
Standard Deviation 0.103
-0.081 logMAR
Standard Deviation 0.110
Best Corrected Visual Acuity
60cm (intermediate) Distance
0.227 logMAR
Standard Deviation 0.119
0.176 logMAR
Standard Deviation 0.139
0.200 logMAR
Standard Deviation 0.154
Best Corrected Visual Acuity
Preferred Distance
0.055 logMAR
Standard Deviation 0.121
0.223 logMAR
Standard Deviation 0.146
0.222 logMAR
Standard Deviation 0.138

Adverse Events

ReSTOR +3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crystalens HD

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crystalens AO

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888-451-3937; 817-568-6725

Results disclosure agreements

  • Principal investigator is a sponsor employee All data and discoveries arising out of the study, patentable or nonpatentable, shall be the sole property of Alcon Laboratories, Inc. Alcon reserves the right of prior review of any publication or presentation of information related to the study. Alcon may use these data now and in the future for presentation or publication at Alcon's discretion or for submission to government regulatory agencies.
  • Publication restrictions are in place

Restriction type: OTHER