Cataract Refractive Suite Study

Not Applicable

Terminated

• Conditions: Cataracts
• Interventions: Device: Cataract Refractive Suite (CRS); Procedure: Standard manual technique

• Registration Number: NCT02974140
• Lead Sponsor: Alcon, a Novartis Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-28
• Study Start: 2017-03-02
• Primary Completion: 2017-07-25
• Study Completion: 2017-07-25
• Results First Submitted: 2018-07-23
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Results First Posted: 2018-09-14
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRS	Cataract Refractive Suite (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.
CRS	Standard manual technique	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.
Manual	Standard manual technique	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.
Manual	Cataract Refractive Suite (CRS)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1	Day 20-40 from second implantation	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Aspiration Fluid Used During Surgery	Day 0 (operative day), each eye	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.
Cumulative Dissipated Energy (CDE)	Day 0 (operative day), each eye	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.
Phaco Aspiration Time Spent During Surgery	Day 0 (operative day), each eye	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Hurst, Texas, United States