Blue Light Intraocular Lenses (IOLs) and Photostress
Study Details
Study Description
Brief Summary
To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 |
Outcome Measures
Primary Outcome Measures
- Photostress Recovery Time in Seconds. [3 months]
The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.
Exclusion Criteria:
- Age related
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Call Alcon Call Center for Study 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.- M07-023
Study Results
Participant Flow
Recruitment Details | Patients with existing bilateral intraocular lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery. |
---|---|
Pre-assignment Detail | Subjects eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria. |
Arm/Group Title | AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients |
---|---|---|---|
Arm/Group Description | AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN" | AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA" | Phakic patients - Age matched patients who have not had cataract surgery |
Period Title: Overall Study | |||
STARTED | 17 | 20 | 21 |
COMPLETED | 16 | 16 | 21 |
NOT COMPLETED | 1 | 4 | 0 |
Baseline Characteristics
Arm/Group Title | AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients | Total |
---|---|---|---|---|
Arm/Group Description | AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN" | AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA" | Phakic patients - Age matched patients who have not had cataract surgery | Total of all reporting groups |
Overall Participants | 17 | 20 | 21 | 58 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
2
11.8%
|
2
10%
|
3
14.3%
|
7
12.1%
|
>=65 years |
15
88.2%
|
18
90%
|
18
85.7%
|
51
87.9%
|
Sex: Female, Male (Count of Participants) | ||||
Female |
11
64.7%
|
13
65%
|
10
47.6%
|
34
58.6%
|
Male |
6
35.3%
|
7
35%
|
11
52.4%
|
24
41.4%
|
Outcome Measures
Title | Photostress Recovery Time in Seconds. |
---|---|
Description | The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients |
---|---|---|---|
Arm/Group Description | AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN" | AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA" | Phakic patients - Age matched patients who have not had cataract surgery |
Measure Participants | 16 | 16 | 21 |
Mean (Standard Deviation) [seconds] |
36
(25.94)
|
41.46
(25.94)
|
24.88
(15.45)
|
Adverse Events
Time Frame | N/A - Not collected | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Serious and/or other [non-serious] adverse events were not collected/assessed | |||||
Arm/Group Title | AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients | |||
Arm/Group Description | AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN" | AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA" | Phakic patients - Age matched patients who have not had cataract surgery | |||
All Cause Mortality |
||||||
AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.
Results Point of Contact
Name/Title | Rick Potvin |
---|---|
Organization | Alcon Research, Ltd. |
Phone | 817-551-4815 |
Rick.Potvin@alconlabs.com |
- M07-023