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Completed

NCT Number: NCT02895074

Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femtosecond laser-assisted cataract surgery

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

Conventional phacoemulsification cataract surgery

Procedure

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

Tropicamide

Drug

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

Proparacaine hydrochloride

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Ministry of Health, China

Registry information

Official study title

Subfoveal Choroidal Thickness After Femtosecond Laser-assisted Cataract Surgery for Age-related Cataracts

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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