Clinical trial NCT02176343: Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
Official title: Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Corneal Astigmatism
Keywords: Cataract
Intraocular lens
ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Detailed description: This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
* Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
* Must complete a visit within 10 days after IOL implantation;
* Successful capsular bag implantation with no surgical complications;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
* Ocular or intraocular infection or inflammation at the time of the preoperative visit;
* Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
* Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
* Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
* Known history of Type 1 or 2 diabetes for more than 5 years;
* Any ocular or systemic co-morbidity at the preoperative visit;
* Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
* Preoperative corneal astigmatism ≤ 0.50 D;
* Participation in another clinical study at the preoperative visit or at the time of the final study visit;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Percent Reduction in Cylinder
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Mean Uncorrected Distance Visual Acuity
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Mean Uncorrected Near Visual Acuity
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Mean Uncorrected Intermediate Visual Acuity
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Mean Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
measure: Mean IOL Rotation
timeFrame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, GCRA, Surgical
role: STUDY_DIRECTOR
References: