Cataract With a Nuclear Sclerosis Grade Between 1 to 3
Conditions
Keywords
Zero CDE technique, FLACS
Brief summary
The Zero CDE (cumulative dissipated energy) technique facilitates cataract removal with no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye. In the investigator's experience, this technique consistently shows a stable anterior chamber, a low complication rate, and a rapid return of vision following cataract surgery. This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS).
Interventions
PROCEDUREFemtosecond laser-assisted cataract surgery using Zero CDE
In this single-arm, non-comparative study, patients with cataract grade 1-3 (LOCS III nuclear sclerosis) will undergo cataract removal with the Zero CDE technique that involves no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye.
Sponsors
Bochner Eye Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients over the age of 50 years with operable cataract of nuclear sclerosis grade 1 to 3 as measured by LOCS III grading system (patients with cortical or posterior subcapsular cataract of any grade will be eligible). * Patients must be able to provide written informed consent for participating in the study. * Preoperative best corrected visual acuity of 20/25 or worse.
Exclusion criteria
* Patients with corneal edema, corneal guttata, pseudoexfoliation, zonular dialysis, or other ocular anomalies (e.g., inflammation, uveitis, previous trauma, suspected microbial infection, glaucoma, and macular disease). * Patients wearing soft contact lenses will need to discontinue lens wear for 2 weeks, and hard contact lens wearers for one month prior to intraocular lens measurements. * Women patients of childbearing potential. * Patients undergoing arcuate keratotomy or other combined surgery with cataract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of cataract cases completed with Zero CDE | Intraoperative |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months |
| Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case. | Intraoperative |
| Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop. | Postoperative Day 1 |
| Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop. | Postoperative 2 weeks, 1 month and 3 months |
| Among the cases requiring CDE, the amount of phaco energy used | Intraoperative |
Countries
Canada
Contacts
CONTACTRaymond Stein, MD, FRCSC
Outcome results
None listed