Trial Outcomes & Findings for Blue Light Intraocular Lenses (IOLs) and Photostress (NCT NCT00710996)
NCT ID: NCT00710996
Last Updated: 2010-02-02
Results Overview
The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.
Recruitment status
COMPLETED
Target enrollment
58 participants
Primary outcome timeframe
3 months
Results posted on
2010-02-02
Participant Flow
Patients with existing bilateral intraocular lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.
Subjects eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Participant milestones
| Measure |
AcrySof Natural Intraocular Lens
AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"
|
AcrySof Clear Intraocular Lens
AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"
|
Phakic Patients
Phakic patients - Age matched patients who have not had cataract surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
21
|
|
Overall Study
COMPLETED
|
16
|
16
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blue Light Intraocular Lenses (IOLs) and Photostress
Baseline characteristics by cohort
| Measure |
AcrySof Natural Intraocular Lens
n=17 Participants
AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"
|
AcrySof Clear Intraocular Lens
n=20 Participants
AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"
|
Phakic Patients
n=21 Participants
Phakic patients - Age matched patients who have not had cataract surgery
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.
Outcome measures
| Measure |
AcrySof Natural Intraocular Lens
n=16 Participants
AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"
|
AcrySof Clear Intraocular Lens
n=16 Participants
AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"
|
Phakic Patients
n=21 Participants
Phakic patients - Age matched patients who have not had cataract surgery
|
|---|---|---|---|
|
Photostress Recovery Time in Seconds.
|
36 seconds
Standard Deviation 25.94
|
41.46 seconds
Standard Deviation 25.94
|
24.88 seconds
Standard Deviation 15.45
|
Adverse Events
AcrySof Natural Intraocular Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AcrySof Clear Intraocular Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phakic Patients
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
Results disclosure agreements
- Principal investigator is a sponsor employee No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.
- Publication restrictions are in place
Restriction type: OTHER