Clinical trial NCT01190631: An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation
Official title: An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: intraocular lens
cataracts
total residual spherical aberration
high order aberrations
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).

Detailed description: Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.

Eligibility criteria: Inclusion Criteria:

* Age-related cataract grade 3 or lower in at least one eye;
* Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
* Able to have an operation within 30 days of preoperative evaluation;
* Good ocular health, with the exception of cataracts;
* ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
* Willing and able to understand and sign an informed consent;
* Willing and able to attend postoperative examinations per protocol schedule;
* Able to achieve 6.5mm dilated pupil;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Preoperative ocular pathology as specified in protocol;
* Preoperative corneal pathology as specified in protocol;
* Keratometric astigmatism exceeding 1.50 diopter;
* Planned postoperative refraction for mono-vision;
* Uncontrolled diabetes;
* Use of any systemic or topical drug known to interfere with visual performance;
* Contact lens use during the active treatment portion of the trial;
* Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial;
* Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
* Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Contrast Sensitivity
timeFrame: Day 90 postoperative
Secondary outcomes:
measure: Total Higher Order Aberrations
timeFrame: Day 90 postoperative
measure: Corneal Spherical Aberration
timeFrame: Day 90 postoperative
measure: Uncorrected Visual Acuity (UCVA)
timeFrame: Day 90 postoperative
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Day 90 postoperative
measure: Low Contrast (10%) Visual Acuity
timeFrame: Day 90 postoperative
measure: Quality of Vision Questionnaire
timeFrame: Day 90 postoperative
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References: