Presbyopia-Correcting Intraocular Lenses (IOLs)

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00963560
Collaborator
(none)
132
1
3

Study Details

Study Description

Brief Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

Condition or Disease Intervention/Treatment Phase
  • Device: ReSTOR +3
  • Device: Crystalens HD
  • Device: Crystalens AO
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: ReSTOR +3

Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)

Device: ReSTOR +3
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.

Active Comparator: Crystalens HD

Bilateral implantation of Crystalens HD Intraocular Lens (IOL)

Device: Crystalens HD
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.

Active Comparator: Crystalens AO

Bilateral implantation of Crystalens AO Intraocular Lens (IOL)

Device: Crystalens AO
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Visual Acuity [6 Months after surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • diagnosed with bilateral cataracts

  • candidate for presbyopic lens

Exclusion Criteria:
  • 1 Diopter preoperative astigmatism by Keratometry readings

  • pre-existing conditions that could skew the results

Contacts and Locations

Locations

Site City State Country Postal Code
1 Contact Alcon Call Center For Trial Locations Fort Worth Texas United States 76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00963560
Other Study ID Numbers:
  • M09-008
First Posted:
Aug 21, 2009
Last Update Posted:
Aug 9, 2011
Last Verified:
Jul 1, 2011
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Bilateral diagnosis of cataracts of subjects >21 years of age.
Pre-assignment Detail During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Arm/Group Title ReSTOR +3 Crystalens HD Crystalens AO
Arm/Group Description Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) Bilateral implantation of Crystalens HD Intraocular Lens (IOL) Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Period Title: Overall Study
STARTED 47 44 41
COMPLETED 44 41 41
NOT COMPLETED 3 3 0

Baseline Characteristics

Arm/Group Title ReSTOR +3 Crystalens HD Crystalens AO Total
Arm/Group Description Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) Bilateral implantation of Crystalens HD Intraocular Lens (IOL) Bilateral implantation of Crystalens AO Intraocular Lens (IOL) Total of all reporting groups
Overall Participants 47 44 41 132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
63.4
(9.4)
64
(7.8)
65.3
(7.5)
64.23
(8.23)
Sex: Female, Male (Count of Participants)
Female
28
59.6%
25
56.8%
26
63.4%
79
59.8%
Male
19
40.4%
19
43.2%
15
36.6%
53
40.2%

Outcome Measures

1. Primary Outcome
Title Best Corrected Visual Acuity
Description 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.
Time Frame 6 Months after surgery

Outcome Measure Data

Analysis Population Description
2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.
Arm/Group Title ReSTOR +3 Crystalens HD Crystalens AO
Arm/Group Description Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) Bilateral implantation of Crystalens HD Intraocular Lens (IOL) Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Measure Participants 42 40 41
4m (far) Distance
-0.075
(0.100)
-0.080
(0.103)
-0.081
(0.110)
60cm (intermediate) Distance
0.227
(0.119)
0.176
(0.139)
0.200
(0.154)
40 cm (near) Distance
0.057
(0.086)
0.364
(0.183)
0.420
(0.188)
Preferred Distance
0.055
(0.121)
0.223
(0.146)
0.222
(0.138)

Adverse Events

Time Frame Day of surgery until visit 6 months following surgery.
Adverse Event Reporting Description
Arm/Group Title ReSTOR +3 Crystalens HD Crystalens AO
Arm/Group Description Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) Bilateral implantation of Crystalens HD Intraocular Lens (IOL) Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
All Cause Mortality
ReSTOR +3 Crystalens HD Crystalens AO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
ReSTOR +3 Crystalens HD Crystalens AO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/47 (0%) 0/44 (0%) 0/41 (0%)
Other (Not Including Serious) Adverse Events
ReSTOR +3 Crystalens HD Crystalens AO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/47 (0%) 0/44 (0%) 0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Director of Alcon Clinical
Organization Alcon Research, Ltd.
Phone 888-451-3937; 817-568-6725
Email medinfo@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00963560
Other Study ID Numbers:
  • M09-008
First Posted:
Aug 21, 2009
Last Update Posted:
Aug 9, 2011
Last Verified:
Jul 1, 2011