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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 39
- Locations
- 4
- Primary Endpoint
- Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Cataract Refractive Suite (CRS) (Device)
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.
Intervention: Standard manual technique (Procedure)
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.
Intervention: Cataract Refractive Suite (CRS) (Device)
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.
Intervention: Standard manual technique (Procedure)
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
Time Frame: 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 Outcomes
- Estimated Aspiration Fluid Used During Surgery(Day 0 (operative day), each eye)
- Cumulative Dissipated Energy (CDE)(Day 0 (operative day), each eye)
- Phaco Aspiration Time Spent During Surgery(Day 0 (operative day), each eye)