N/A
N=390
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Intumescent Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02403206 ↗Enrolled (actual)
390
Serious AEs
4.0%
Results posted
Jul 2017
Primary outcome: Primary: Percentage of Capsular Tears (Anterior or Posterior) During Surgery — 5.3; 5.3 percentage of capsular tears
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Femtosecond laser (Device); Continuous Curvilinear Capsulorhexis (CCC) (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon, a Novartis Company
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Capsular Tears (Anterior or Posterior) During Surgery |
5.3; 5.3 | — |
| SECONDARY Operating Time in the Eye to Complete Entire Cataract Procedure |
795.0; 856.6 | — |
Summary
The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.
Eligibility Criteria
Inclusion Criteria
- Willing to undergo cataract surgery.
- Able to lie flat in a supine position.
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Pregnant or lactating mothers.
- Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
- Corneal opacity that would interfere with the laser beam.
- Presence of blood or other material in the anterior chamber.
- Hypotony or presence of corneal implant.
- Poorly dilating pupils.
- Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
- Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
- Any contraindication to cataract surgery.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02403206). 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.