Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

Cataract Clinical Trial

Official title:

A Three Arm Prospective Clinical Evaluation of Three FDA-approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225952
• Other study ID #: 656
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2010
• Last updated: December 11, 2012
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

• Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.

• Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes.

• Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.

• At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture.

• Subjects must have = 1.25 D of preoperative corneal astigmatism in both eyes.

Exclusion Criteria:

• Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse.

• 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 nonproliferative) which reduces potential acuity to 20/32 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 20/32 or worse.

• Subjects with optic atrophy.

• Subjects with iris neovascularization.

• Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Crystalens AO
Bausch & Lomb model silicone multi-piece accommodating IOL.
• ReSTOR 3.0
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
• AMO Tecnis Multifocal
The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.

Locations

Country	Name	City	State
Philippines	Asian Eye Institute	Makati City

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Primary	Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)	In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 3 (day 30-60)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No
Secondary	Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.	Postoperative visit 4 (day 120-180)	No