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Trial record 35 of 1150 for:    cataract

Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

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ClinicalTrials.gov Identifier: NCT02895074
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: Femtosecond laser-assisted cataract surgery Procedure: Conventional phacoemulsification cataract surgery Drug: Tropicamide Drug: Proparacaine hydrochloride Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subfoveal Choroidal Thickness After Femtosecond Laser-assisted Cataract Surgery for Age-related Cataracts
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: femtosecond laser-assisted cataract surgery group 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.

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

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

Experimental: conventional phacoemulsification surgery group 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.

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

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




Primary Outcome Measures :
  1. The change of subfoveal choroidal thickness [ Time Frame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery ]
    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 :
  1. The change of subfoveal retinal thickness [ Time Frame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895074


Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
Investigators
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

Additional Information:
Publications:
Responsible Party: Haotian Lin, Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02895074     History of Changes
Other Study ID Numbers: CCPMOH2016-China7
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016

Keywords provided by Haotian Lin, Sun Yat-sen University:
femtosecond laser-assisted cataract surgery (FLACS)
subfoveal choroidal thickness (SFCT)
conventional phacoemulsification surgery (CPS)

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Tropicamide
Proxymetacaine
Propoxycaine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents