Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
NCT ID: NCT02492659
Last Updated: 2015-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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It is still unknown whether there are toxic substances produced due to photochemical or high-energy physical effect of femtosecond laser during FLACS.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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trial group
the trial group underwent femtosecond laser-assisted cataract surgery
femtosecond laser-assisted cataract surgery
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.
control group
the control group underwent conventional phacoemulsification
conventional 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
Interventions
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femtosecond laser-assisted cataract surgery
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.
conventional 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
Eligibility Criteria
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Inclusion Criteria
2. dilated pupillary diameter greater than 6mm
3. no local or systemic contraindications to cataract surgery
Exclusion Criteria
2. glaucoma
3. ocular inflammation
4. previous ocular trauma or surgery
38 Years
86 Years
ALL
Yes
Sponsors
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Wenzhou Medical University
OTHER
Responsible Party
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A-Yong Yu
clinical professor
Principal Investigators
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A-Yong Yu, PhD
Role: PRINCIPAL_INVESTIGATOR
Wenzhou Medical University
Locations
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Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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Femtosecond Laser
Identifier Type: -
Identifier Source: org_study_id
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