Blue Light Intraocular Lenses (IOLs) and Photostress

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00710996
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 6.4

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
Cataract

Study Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Blue Light Intraocular Lenses (IOLs) and Photostress
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

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

1. 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

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

• ClinicalTrials.gov Identifier: NCT00710996
• Other Study ID Numbers: M07-023
• First Posted: Jul 8, 2008
• Last Update Posted: Feb 2, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: AcrySof IQ IOL
• Additional relevant MeSH terms: Cataract

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

1. Primary Outcome

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

[Not Specified]

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.