Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02895074

Collaborator

Ministry of Health, China (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Femtosecond laser-assisted cataract surgery Procedure: Conventional phacoemulsification cataract surgery Drug: Tropicamide Drug: Proparacaine hydrochloride	N/A

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 Design

Study Type:

Interventional

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 :

Aug 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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