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Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Femtosecond laser-assisted cataract surgery
Conventional phacoemulsification cataract surgery
Tropicamide
Proparacaine hydrochloride
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring femtosecond laser-assisted cataract surgery (FLACS), subfoveal choroidal thickness (SFCT), conventional phacoemulsification surgery (CPS)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

femtosecond laser-assisted cataract surgery group

conventional phacoemulsification surgery group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2016
Last Updated
September 5, 2016
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China
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1. Study Identification

Unique Protocol Identification Number
NCT02895074
Brief Title
Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts
Official Title
Subfoveal Choroidal Thickness After Femtosecond Laser-assisted Cataract Surgery for Age-related Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
femtosecond laser-assisted cataract surgery (FLACS), subfoveal choroidal thickness (SFCT), conventional phacoemulsification surgery (CPS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
femtosecond laser-assisted cataract surgery group
Arm Type
Experimental
Arm Title
conventional phacoemulsification surgery group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Femtosecond laser-assisted cataract surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional phacoemulsification cataract surgery
Intervention Description
Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.
Intervention Type
Drug
Intervention Name(s)
Tropicamide
Intervention Description
After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications
Intervention Type
Drug
Intervention Name(s)
Proparacaine hydrochloride
Intervention Description
topical anesthesia with proparacaine hydrochloride (0.5%) was applied.
Primary Outcome Measure Information:
Title
The change of subfoveal choroidal thickness
Description
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.
Time Frame
baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Secondary Outcome Measure Information:
Title
The change of subfoveal retinal thickness
Description
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.
Time Frame
baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Weirong Chen, M.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26269445
Citation
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.
Results Reference
background
Links:
URL
http://www.gzzoc.com/
Description
Description Home page of Zhongshan Ophthalmic Center
URL
http://www.cnccclub.com/
Description
Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)

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Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

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