Cataract Refractive Suite Study

Cataracts Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02974140
• Other study ID #: CTK246-P001
• Status: Terminated
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: July 25, 2017

Study information

• Verified date: August 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: July 25, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• 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

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

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Hurst	Texas
United States	Alcon Investigative Site	Panama City	Florida
United States	Alcon Investigative Site	Stillwater	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 20-40 from second implantation
Secondary	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.	Day 0 (operative day), each eye
Secondary	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.	Day 0 (operative day), each eye
Secondary	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.	Day 0 (operative day), each eye

External Links

•   Results from the Novartis Clinical Trial Results Website