Cataract Refractive Suite Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2017-07-25

Brief Summary

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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

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Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CRS

First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery.

Group Type EXPERIMENTAL

Cataract Refractive Suite (CRS)

Intervention Type 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 technique

Intervention Type PROCEDURE

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

Manual

First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery.

Group Type ACTIVE_COMPARATOR

Cataract Refractive Suite (CRS)

Intervention Type 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 technique

Intervention Type PROCEDURE

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

Interventions

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Cataract Refractive Suite (CRS)

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

Intervention Type DEVICE

Standard manual technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;

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;

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No