Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts
1 other identifier
interventional
40
1 country
1
Brief Summary
To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in age-related cataracts.
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 Aug 2014
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
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedSeptember 9, 2016
September 1, 2016
10 months
August 29, 2016
September 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change of subfoveal choroidal thickness
The subfoveal choroidal thickness were measured at baseline and at 1 day, 7 days , 1 month , and 3 months postoperatively by spectral-domain optical coherence tomography.
baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Secondary Outcomes (1)
The change of subfoveal retinal thickness
baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Study Arms (2)
femtosecond laser-assisted cataract surgery group
EXPERIMENTALconventional phacoemulsification surgery group
EXPERIMENTALInterventions
A femtosecond laser (Alcon-Lensx, Alcon-Lensx, Inc.) was used in this study. After pupil dilation and topical anesthesia, the laser was docked to the eye using a curved contact lens to applanate the cornea. With the integrated OCT imaging system, the locations of the cornea and the anterior and posterior surfaces of the crystalline lens were determined. A 5.0-mm-diameter capsulotomy was created by scanning a cylindrical pattern and followed by lens fragmentation. The laser was disconnected, and the remainder of the surgery was performed as phacoemulsification (Infiniti® Vision System; Alcon, USA). Folded intraocular lenses (IOLs) were implanted in the capsular bags.
Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.
After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications
topical anesthesia with proparacaine hydrochloride (0.5%) was applied.
Eligibility Criteria
You may qualify if:
- The cataract stages of the patients were between N2 and N4 according to the LOCS III.
You may not qualify if:
- eyes with histories of ocular surgery, trauma, and ocular diseases, including diabetic retinopathy, age-related macular degeneration (AMD), high myopia, psudoexfoliation, uveitis, retinal vein occlusion, and other inflammatory and vascular retinal disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Ministry of Health, Chinacollaborator
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Related Publications (1)
Chen X, Xiao W, Ye S, Chen W, Liu Y. Efficacy and safety of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification for cataract: a meta-analysis of randomized controlled trials. Sci Rep. 2015 Aug 13;5:13123. doi: 10.1038/srep13123.
PMID: 26269445BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haotian Lin, M.D., Ph.D
Zhongshan Ophthalmic Center, Sun Yat-sen University
- STUDY CHAIR
Yizhi Liu, M.D., Ph.D
Zhongshan Ophthalmic Center, Sun Yat-sen University
- STUDY DIRECTOR
Weirong Chen, M.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 9, 2016
Study Start
August 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 9, 2016
Record last verified: 2016-09