Clinical Research of Femtosecond Laser-Assisted Cataract Surgery (FLACS)
Primary Purpose
Cataracts
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
femtosecond laser-assisted cataract surgery
conventional phacoemulsification
Sponsored by

About this trial
This is an interventional treatment trial for Cataracts focused on measuring femtosecond laser
Eligibility Criteria
Inclusion Criteria:
- normal cornea
- dilated pupillary diameter greater than 6mm
- no local or systemic contraindications to cataract surgery
Exclusion Criteria:
- corneal pathological changes
- glaucoma
- ocular inflammation
- previous ocular trauma or surgery
Sites / Locations
- Eye Hispital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
trial group
control group
Arm Description
the trial group underwent femtosecond laser-assisted cataract surgery
the control group underwent conventional phacoemulsification
Outcomes
Primary Outcome Measures
the proteins in the aqueous humor after femtosecond laser operation
Secondary Outcome Measures
the electrolyte in the aqueous humor after femtosecond laser operation
morphology of the anterior capsule after femtosecond laser operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02492659
Brief Title
Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
Acronym
FLACS
Official Title
Clinical Research of Femtosecond Laser-Assisted Cataract Surgery: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
femtosecond laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trial group
Arm Type
Experimental
Arm Description
the trial group underwent femtosecond laser-assisted cataract surgery
Arm Title
control group
Arm Type
Other
Arm Description
the control group underwent conventional phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
femtosecond laser-assisted cataract surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional phacoemulsification
Intervention Description
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
Primary Outcome Measure Information:
Title
the proteins in the aqueous humor after femtosecond laser operation
Time Frame
day 1
Secondary Outcome Measure Information:
Title
the electrolyte in the aqueous humor after femtosecond laser operation
Time Frame
day 1
Title
morphology of the anterior capsule after femtosecond laser operation
Time Frame
day 1
Other Pre-specified Outcome Measures:
Title
phacoemulsification energy
Time Frame
in operation
Title
phacoemulsification time
Time Frame
in operation
Title
postoperative refraction
Time Frame
day 1,after one week
Title
the capsulorhexis size
Time Frame
after one month,after three month
Title
corneal endothelial density
Time Frame
after one month,after three month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
normal cornea
dilated pupillary diameter greater than 6mm
no local or systemic contraindications to cataract surgery
Exclusion Criteria:
corneal pathological changes
glaucoma
ocular inflammation
previous ocular trauma or surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A-Yong Yu, PhD
Organizational Affiliation
Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hispital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
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