Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

NCT ID: NCT02895074

Last Updated: 2016-09-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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femtosecond laser-assisted cataract surgery group

Group Type EXPERIMENTAL

Femtosecond laser-assisted cataract surgery

Intervention Type PROCEDURE

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 (InfinitiĀ® Vision System; Alcon, USA). Folded intraocular lenses (IOLs) were implanted in the capsular bags.

Tropicamide

Intervention Type DRUG

After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications

Proparacaine hydrochloride

Intervention Type DRUG

topical anesthesia with proparacaine hydrochloride (0.5%) was applied.

conventional phacoemulsification surgery group

Group Type EXPERIMENTAL

Conventional phacoemulsification cataract surgery

Intervention Type PROCEDURE

Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.

Tropicamide

Intervention Type DRUG

After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications

Proparacaine hydrochloride

Intervention Type DRUG

topical anesthesia with proparacaine hydrochloride (0.5%) was applied.

Interventions

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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 (InfinitiĀ® Vision System; Alcon, USA). Folded intraocular lenses (IOLs) were implanted in the capsular bags.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Tropicamide

After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications

Intervention Type DRUG

Proparacaine hydrochloride

topical anesthesia with proparacaine hydrochloride (0.5%) was applied.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haotian Lin, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Yizhi Liu, M.D., Ph.D

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Weirong Chen, M.D.

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26269445 (View on PubMed)

Related Links

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http://www.gzzoc.com/

Description Home page of Zhongshan Ophthalmic Center

Other Identifiers

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CCPMOH2016-China7

Identifier Type: -

Identifier Source: org_study_id

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