A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

Cataract Clinical Trial

Official title:

A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257217
• Other study ID #: M09-051
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Description:

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Sign informed consent;

• Able to attend postoperative examinations per protocol schedule;

• Diagnosed with bilateral cataracts;

• Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);

• Preoperative astigmatism = 2.5 diopter;

• Good ocular health, with the exception of cataracts;

• Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;

• Able to undergo second eye surgery within one month of the first eye surgery;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Previous corneal surgery;

• Planned multiple procedures during cataract/IOL implantation surgery;

• Any ocular disease and/or condition that may compromise study results;

• Pregnant or planning pregnancy during course of study;

• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)

• Diabetic retinopathy;

• Macular degeneration;

• History of retinal detachment;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
• AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
• Acri.LISA® 366D IOL
Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient
• Acri.LISA® 466TD Toric IOL
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Binocular Defocus VA at Month 3	Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.	Month 3 from second eye implantation
Secondary	Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3	Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.	Month 3 from second eye implantation
Secondary	Uncorrected Visual Acuity Across a Range of Distances at Month 3	VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.	Month 3 from second eye implantation
Secondary	Mean Refractive Spherical Equivalent at Month 3	A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.	Month 3 from second eye implantation
Secondary	Mean Radner Reading Speed	Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.	Month 3 from second eye implantation
Secondary	Patient Reported Outcomes at Month 3	The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.	Month 3 from second eye implantation

External Links

•   Results from the Novartis Clinical Trial Results Website