Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Femtosecond laser-assisted cataract surgery
* Procedure: Conventional phacoemulsification cataract surgery
* Drug: Tropicamide
* Drug: Proparacaine hydrochloride


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: femtosecond laser-assisted cataract surgery group<br> | Procedure: Femtosecond laser-assisted cataract surgery<br>* 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.<br>Drug: Tropicamide<br>* After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications<br>Drug: Proparacaine hydrochloride<br>* topical anesthesia with proparacaine hydrochloride (0.5%) was applied.<br>|
| Experimental: conventional phacoemulsification surgery group<br> | Procedure: Conventional phacoemulsification cataract surgery<br>* Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.<br>Drug: Tropicamide<br>* After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications<br>Drug: Proparacaine hydrochloride<br>* topical anesthesia with proparacaine hydrochloride (0.5%) was applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femtosecond laser-assisted cataract surgery (FLACS), subfoveal choroidal thickness (SFCT), conventional phacoemulsification surgery (CPS)