Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895074
• Other study ID #: CCPMOH2016-China7
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 5, 2016
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery	No
Secondary	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.	baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery	No

External Links

•   Description Home page of Zhongshan Ophthalmic Center
•   Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)