CompletedNCT00758550Updated Mar 16, 2010Results posted

Visual Function After Bilateral Implantation of AcrySof® Toric

A Phase 4 interventional study of AcrySof® Toric IOL and AcrySof Natural in Visual Function, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-03-16.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study summary

The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Conditions studied

Visual Function

Keywords

Visual function;
Refractive cylinder;
AcrySof® Toric;
AcrySof® Natural

In context

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Bilateral cataracts
40\~80 years of age
4 Days - 1 Week interval between a single patient's surgery
dilated pupil size (in dim light) ≥ 4.0 mm
Anticipated correction with an IOL of +10 Diopters \~ +25 Diopters
0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion criteria

Exclusion Criteria:

Preoperative ocular pathology
Previous intraocular or corneal surgery
An increased risk for complications which could require vitreoretinal surgery
Corneal irregularities
Corneal opacities
Current contact lens usage(within 6 months prior to first surgery)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

Experimental
AcrySof Toric IOL
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof® Toric IOL
Active comparator
AcrySof Natural IOL
AcrySof Natural Intraocular Lens (IOL)
Device: AcrySof Natural

Interventions

DeviceAcrySof® Toric IOL
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
DeviceAcrySof Natural
AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

What researchers measure

Primary outcomes

Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time frame: 6 Months after surgery

Secondary outcomes

Questionnaire Results
Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).
Time frame: 6 Months

Results

Posted Mar 16, 2010

Participant flow

60 cataract patients were enrolled into the study

Participant flow — Overall Study
Milestone	AcrySof Toric IOL	AcrySof Natural IOL
Started	30	30
Completed	30	30
Not completed	0	0

Outcome measures

PrimaryUncorrected Visual Acuity (UCVA)

Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Time frame:: 6 Months after surgery
Reported as:: Mean · logMAR

Uncorrected Visual Acuity (UCVA)
logMAR	AcrySof Toric IOL	AcrySof Natural IOL
Uncorrected Visual Acuity (UCVA)	0.06 ± 0.14	0.14 ± 0.11

SecondaryQuestionnaire Results

Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).

Time frame:: 6 Months
Reported as:: Mean · Units on a scale

Questionnaire Results
Units on a scale	AcrySof Toric IOL	AcrySof Natural IOL
Questionnaire Results	5.6 ± 0.7	4.5 ± 0.7

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AcrySof Toric IOL	—	0/30 (0%)	0/30 (0%)
AcrySof Natural IOL	—	0/30 (0%)	0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	AcrySof Toric IOL	AcrySof Natural IOL	Total
<=18 years	0	0	0
Between 18 and 65 years	12	15	27
>=65 years	18	15	33

Sex: Female, Male
Sex: Female, Male(Participants)	AcrySof Toric IOL	AcrySof Natural IOL	Total
Female	17	16	33
Male	13	14	27

Study locations

1 site

Alcon Call Center
Fort Worth, Texas 76134, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00758550
Lead sponsor: Alcon Research
First posted: Sep 25, 2008
Start date: Apr 2007
Primary completion: Jun 2008
Results posted: Mar 16, 2010
Last update: Mar 16, 2010

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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