Trial Outcomes & Findings for Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses (NCT NCT01241279)
NCT ID: NCT01241279
Last Updated: 2014-11-26
Results Overview
The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
TERMINATED
PHASE4
6 participants
Visit 4 (postoperative day 120-180)
2014-11-26
Participant Flow
A total of 6 subjects (11 eyes) were enrolled at one investigational site in the US. First participant enrolled 10/26/2010; last participant visit 12/01/2011.
Due to the small sample size, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
Participant milestones
| Measure |
Crystalens AO
A silicone multi-piece accommodating intraocular lens
|
SoftPort LI61AO
A silicone multi-piece foldable aspheric intraocular lens
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Crystalens AO
A silicone multi-piece accommodating intraocular lens
|
SoftPort LI61AO
A silicone multi-piece foldable aspheric intraocular lens
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Baseline characteristics by cohort
| Measure |
Crystalens AO
n=4 Participants
A silicone multi-piece accommodating intraocular lens
|
SoftPort LI61AO
n=2 Participants
A silicone multi-piece foldable aspheric intraocular lens
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 54 to 70 years
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (postoperative day 120-180)Population: DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: All visits through visit 4 (day 160-180)Population: DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.
Outcome measures
Outcome data not reported
Adverse Events
Crystalens AO
SoftPort LI61AO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Johnson Varughese
Valeant Pharmaceuticals/Bausch & Lomb
Results disclosure agreements
- Principal investigator is a sponsor employee Study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER