N/A
N=55
Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT03479944 ↗Enrolled (actual)
55
Serious AEs
1.2%
Results posted
Dec 2019
Primary outcome: Primary: Cumulative Dissipated Energy (CDE) — 0.213; 1.718 unitless — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FLACS (Procedure); Manual conventional surgery (Procedure); CENTURION® Vision System (Device); LenSx® (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Dissipated Energy (CDE) |
0.213; 1.718 | <0.0001 sig |
| SECONDARY Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit |
-1.5; -2.7 | 0.2602 |
| SECONDARY Percentage of Average Torsional Amplitude |
19.57; 31.09 | — |
Summary
The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes;
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Calculated lens power within the available range;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any pathology that could reduce visual potential;
- Hypotony or the presence of a corneal implant;
- Residual, recurrent, active ocular or eyelid disease;
- Poorly dilating pupil;
- Any contraindication to cataract;
- Eyes with two different levels of cataract grade;
- Pregnant, or planned pregnancy during the study;
- Expected to require an ocular surgical treatment at any time during the study;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03479944). 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.