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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257217

Enrollment

Registered

2010-12-09

Start date

2010-11-30

Completion date

2011-06-30

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Intraocular Lens, Presbyopia, multifocal

Brief 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.

Detailed 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.

Interventions

DEVICEAcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

DEVICEAcrySof® 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

DEVICEAcri.LISA® 366D IOL

Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient

DEVICEAcri.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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Binocular Defocus VA at Month 3	Month 3 from second eye implantation	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.

Secondary

Measure	Time frame	Description
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3	Month 3 from second eye implantation	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.
Uncorrected Visual Acuity Across a Range of Distances at Month 3	Month 3 from second eye implantation	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.
Mean Refractive Spherical Equivalent at Month 3	Month 3 from second eye implantation	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.
Mean Radner Reading Speed	Month 3 from second eye implantation	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.
Patient Reported Outcomes at Month 3	Month 3 from second eye implantation	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.

Participant flow

Recruitment details

Subjects were recruited from one investigative site located in Spain.

Pre-assignment details

Of the 31 enrolled participants, 1 exited prior to randomization due to withdrawn consent and 5 discontinued after randomization due to adverse event (1) and protocol deviation (4). This reporting group includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).

Participants by arm

Arm	Count
ReSTOR +3 AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation	15
Acri.LISA Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation	10
Total	25

Baseline characteristics

Characteristic	ReSTOR +3	Acri.LISA	Total
Age, Customized < 21 years	0 participants	0 participants	0 participants
Age, Customized ≥ 21 years	15 participants	10 participants	25 participants
Region of Enrollment Spain	15 participants	10 participants	25 participants
Sex: Female, Male Female	9 Participants	8 Participants	17 Participants
Sex: Female, Male Male	6 Participants	2 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	10 / 17	1 / 13
serious Total, serious adverse events	2 / 17	0 / 13

Outcome results

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.

Time frame: Month 3 from second eye implantation