Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Femtosecond laser-assisted cataract surgery; Procedure: Conventional phacoemulsification cataract surgery; Drug: Tropicamide; Drug: Proparacaine hydrochloride

• Registration Number: NCT02895074
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-08-29
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-05
• Last Update Submitted: 2016-09-05
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
femtosecond laser-assisted cataract surgery group	Femtosecond laser-assisted cataract surgery	-
femtosecond laser-assisted cataract surgery group	Tropicamide	-
conventional phacoemulsification surgery group	Conventional phacoemulsification cataract surgery	-
conventional phacoemulsification surgery group	Proparacaine hydrochloride	-
femtosecond laser-assisted cataract surgery group	Proparacaine hydrochloride	-
conventional phacoemulsification surgery group	Tropicamide	-

Primary Outcome Measures

Name	Time	Method
The change of subfoveal choroidal thickness	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

Name	Time	Method
The change of subfoveal retinal thickness	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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China