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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02895074
Other study ID # CCPMOH2016-China7
Secondary ID
Status Completed
Phase N/A
First received August 29, 2016
Last updated September 5, 2016
Start date August 2014
Est. completion date June 2015

Study information

Verified date September 2016
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

It is not clear whether femtosecond laser-assisted cataract surgery (FLACS) alters retinal and choroidal thickness. The goal of the present study was to determine the changes of retinal and choroidal thicknesses in patients who have undergone FLACS compared to patients who have undergone conventional phacoemulsification surgery (CPS).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- The cataract stages of the patients were between N2 and N4 according to the LOCS III.

Exclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Femtosecond laser-assisted cataract surgery
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.
Conventional phacoemulsification cataract surgery
Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.
Drug:
Tropicamide
After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications
Proparacaine hydrochloride
topical anesthesia with proparacaine hydrochloride (0.5%) was applied.

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Ministry of Health, China

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary The change of subfoveal retinal thickness The subfoveal retinal 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 No
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