Presbyopia-Correcting Intraocular Lenses (IOLs)
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 |
---|---|---|
|
Phase 4 |
Study Design
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
- 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
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.- M09-008
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
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
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 |
medinfo@alconlabs.com |
- M09-008