Cataract Refractive Suite Study

Alcon, a Novartis Company39 enrolled

Overview

The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cataracts

Interventions

Cataract Refractive Suite (CRS)DEVICE

Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery

Standard manual techniquePROCEDURE

Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with bilateral cataracts; * Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes; * Clear intraocular media, other than cataract, in study eye(s); * Willing and able to complete all required postoperative visits; * Able to comprehend and sign a statement of informed consent; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Significant irregular corneal astigmatism; * History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease; * Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment; * Any inflammation or edema (swelling) of the cornea; * Pregnant; * Other protocol-specified exclusion criteria may apply.

Locations (3)

Alcon Investigative Site

Panama City, Florida, United States

Alcon Investigative Site

Stillwater, Minnesota, United States

Alcon Investigative Site

Hurst, Texas, United States

Outcomes

Primary Outcomes

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1

Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Time frame: Day 20-40 from second implantation

Secondary Outcomes

Cumulative Dissipated Energy (CDE)

Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Time frame: Day 0 (operative day), each eye

Estimated Aspiration Fluid Used During Surgery

Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Time frame: Day 0 (operative day), each eye

Phaco Aspiration Time Spent During Surgery

Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Time frame: Day 0 (operative day), each eye

Data from ClinicalTrials.gov

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