Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01241279
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Crystalens AO; Device: SoftPort LI61AO	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crystalens AO A silicone multi-piece accommodating intraocular lens	Device: Crystalens AO; Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.
Active Comparator: SoftPort LI61AO A silicone multi-piece foldable aspheric intraocular lens	Device: SoftPort LI61AO; Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.

Outcome Measures

Primary Outcome Measures

1. Amplitude of Accommodation [Visit 4 (postoperative day 120-180)]

   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.

Secondary Outcome Measures

1. Visual Acuity [All visits through visit 4 (day 160-180)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have clear intraocular media other than cataract.

• Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.

• Subjects must be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.

• Subjects must require a spherical lens power from 10.00 D to 30.00 D.

• Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.

• Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

Exclusion Criteria:

• Subjects with corneal pathology potentially affecting topography.

• Subjects whose fundus cannot be assessed preoperatively.

• Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.

• Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.

• Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.

• Subjects with uncontrolled glaucoma.

• Subjects with previous retinal detachment.

• Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/30 or worse.

• Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.

• Subjects with marked microphthalmos or aniridia.

• Subjects who have had previous corneal surgery.

• Subjects with irregular corneal astigmatism.

• Subjects with amblyopia which reduces potential acuity to worse than 20/30.

• Subjects with optic atrophy.

• Subjects with iris neovascularization.

• Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.

• Subjects with chronic use of systemic steroids or immunosuppressive medications.

• Subjects lacking intact binocular vision.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Johnson Varughese, Valeant Pharmaceuticals/Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01241279
• Other Study ID Numbers: 657
• First Posted: Nov 16, 2010
• Last Update Posted: Nov 26, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Bausch & Lomb Incorporated: cataract surgery; intraocular lens
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	Due to the small sample size, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.

Arm/Group Title	Crystalens AO	SoftPort LI61AO
Arm/Group Description	A silicone multi-piece accommodating intraocular lens	A silicone multi-piece foldable aspheric intraocular lens
Period Title: Overall Study
STARTED	4	2
COMPLETED	4	1
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Crystalens AO	SoftPort LI61AO	Total
Arm/Group Description	A silicone multi-piece accommodating intraocular lens	A silicone multi-piece foldable aspheric intraocular lens	Total of all reporting groups
Overall Participants	4	2	6
Age, Customized (participants) [Number]
Age 54 to 70 years	4 100%	2 100%	6 100%
Sex: Female, Male (Count of Participants)
Female	2 50%	1 50%	3 50%
Male	2 50%	1 50%	3 50%

Outcome Measures

1. Primary Outcome

Title	Amplitude of Accommodation
Description	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.
Time Frame	Visit 4 (postoperative day 120-180)

Outcome Measure Data

Analysis Population Description

DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.

Arm/Group Title	Crystalens AO	SoftPort LI61AO
Arm/Group Description	A silicone multi-piece accommodating intraocular lens	A silicone multi-piece foldable aspheric intraocular lens
Measure Participants	0	0

2. Secondary Outcome

Title	Visual Acuity
Description	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.
Time Frame	All visits through visit 4 (day 160-180)

Outcome Measure Data

Analysis Population Description

DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.

Arm/Group Title	Crystalens AO	SoftPort LI61AO
Arm/Group Description	A silicone multi-piece accommodating intraocular lens	A silicone multi-piece foldable aspheric intraocular lens
Measure Participants	0	0

Adverse Events

Time Frame	180 days
Arm/Group Title	Crystalens AO		SoftPort LI61AO
Arm/Group Description	A silicone multi-piece accommodating intraocular lens		A silicone multi-piece foldable aspheric intraocular lens
All Cause Mortality
	Crystalens AO		SoftPort LI61AO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Crystalens AO		SoftPort LI61AO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Crystalens AO		SoftPort LI61AO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/2 (0%)

Limitations/Caveats

Study terminated early due to lack of enrollment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.