Cataracts
Conditions
Keywords
femtosecond laser
Brief summary
Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced phacoemulsification power and time, and comparable refractive outcome in clinic. It is still unknown whether there are toxic substances produced due to photochemical or high-energy physical effect of femtosecond laser during FLACS.
Detailed description
Phacoemulsification is one of the main surgical procedures for cataract surgery owing to the advantages of small incisions and rapid recovery. However, the surgical outcome of phacoemulsification can be negatively affected due to the problem of accuracy and repeatability for capsulorhexis, and the corneal endothelial cell damage by ultrasound energy.To overcome those problems from the phacoemulsification, femtosecond laser-assisted cataract surgery (FLACS) had been used in the past few years and showed unique advantages. The purpose of this study is to investigate the preliminary clinical outcomes of femtosecond laser-assisted cataract surgery.This prospective comparative study enrolled consecutive patients,will be randomly assigned to trial group underwent FLACS and control group underwent conventional cataract surgery. The phacoemulsification time, energy, and complications during operation were recorded. The anterior capsule and aqueous humor were collected. Morphology of the cutting edge and cells of anterior capsule was assessed by light microscopy. The proteins in the aqueous humor were identified by mass spectrometry . Electrolyte in the aqueous humor was detected by a chemistry analyzer. Postoperative refraction at 1 day, 1 week, 1 and 3 months, the capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured.
Interventions
the femtosecond laser platform was used to generate capsulotomy with a diameter as described above in the control group, and lens fragmentation into 6 segments.
PROCEDUREconventional phacoemulsification
continuous curvilinear capsulorhexis was performed with capsulorrhexis forceps. Following hydrodissection, phacoemulsification of the nucleus, aspiration of the residual cortex and capsular polishing were performed using a phacoemulsification machine
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
38 Years to 86 Years
Healthy volunteers
Yes
Inclusion criteria
1. normal cornea 2. dilated pupillary diameter greater than 6mm 3. no local or systemic contraindications to cataract surgery
Exclusion criteria
1. corneal pathological changes 2. glaucoma 3. ocular inflammation 4. previous ocular trauma or surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proteins in the aqueous humor after femtosecond laser operation | day 1 |
Secondary
| Measure | Time frame |
|---|---|
| the electrolyte in the aqueous humor after femtosecond laser operation | day 1 |
| morphology of the anterior capsule after femtosecond laser operation | day 1 |
Other
| Measure | Time frame |
|---|---|
| the capsulorhexis size | after one month,after three month |
| phacoemulsification energy | in operation |
| corneal endothelial density | after one month,after three month |
| phacoemulsification time | in operation |
| postoperative refraction | day 1,after one week |
Countries
China
Outcome results
None listed