N/A N=150 Single-blind Other

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT02842151 ↗

Enrolled (actual)

150

Serious AEs

2.0%

Results posted

Jan 2019

Primary outcome: Primary: IOL A-constant at 3 Months at Each Site — 119.23; 119.18; 118.86; 118.93 unitless

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Manifest refraction (Procedure); ACRYSOF® IQ Monofocal IOL Model SN60WF (Device); Topcon® KR-1W Wave-Front Analyzer (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY IOL A-constant at 3 Months at Each Site	119.23; 119.18; 118.86; 118.93; 118.39; 118.52	—

Summary

The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.

Eligibility Criteria

Inclusion Criteria

Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
Willing and able to attend all scheduled study visits as required per protocol;
Diagnosed with cataract in one or both eyes;
Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
Preoperative keratometric astigmatism ≤ 1.0 diopter (D);
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Women of childbearing potential, pregnant, or breast-feeding;
History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
Previous intraocular or corneal surgery;
Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02842151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.