Cataract Refractive Suite Study

Alcon

Status: Terminated

Conditions: Cataracts

Treatments: Device: Cataract Refractive Suite (CRS); Procedure: Standard manual technique

Study type: Interventional

Funder types: Industry

Identifiers

NCT02974140

CTK246-P001

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

CRS

Experimental group

Description:

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.

Treatment:

Procedure: Standard manual technique

Device: Cataract Refractive Suite (CRS)

Manual

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard manual technique

Device: Cataract Refractive Suite (CRS)