Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
FLACS
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedJuly 9, 2015
July 1, 2015
5 months
June 19, 2015
July 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the proteins in the aqueous humor after femtosecond laser operation
day 1
Secondary Outcomes (2)
the electrolyte in the aqueous humor after femtosecond laser operation
day 1
morphology of the anterior capsule after femtosecond laser operation
day 1
Other Outcomes (5)
phacoemulsification energy
in operation
phacoemulsification time
in operation
postoperative refraction
day 1,after one week
- +2 more other outcomes
Study Arms (2)
trial group
EXPERIMENTALthe trial group underwent femtosecond laser-assisted cataract surgery
control group
OTHERthe control group underwent conventional phacoemulsification
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.
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
Eligibility Criteria
You may qualify if:
- normal cornea
- dilated pupillary diameter greater than 6mm
- no local or systemic contraindications to cataract surgery
You may not qualify if:
- corneal pathological changes
- glaucoma
- ocular inflammation
- previous ocular trauma or surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A-Yong Yu, PhD
Wenzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
June 19, 2015
First Posted
July 9, 2015
Study Start
October 1, 2013
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
July 9, 2015
Record last verified: 2015-07