A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy

Study Overview
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Brief Summary
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To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery

Detailed Description
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To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.

Official Title
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A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy

Conditions
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Optical Coherence Tomography, Diabetic Retinopathy, Choroid

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged⩾40years; intraocular pressure (IOP) < 21 mm Hg in both eyes, spherical refractive error<6 diopters spherical equivalent. Exclusion Criteria: previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>the age-related cataract patients | |
| DR group<br>the cataract patients with mild/moderate NPDR | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVI at baseline | choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area. | CVI was assessed at baseline(within 1 week before surgery) | 
| CVI at 1 week postoperatively | choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area. | CVI was assessed 1 week after surgery. | 
| CVI at 1 month postoperatively | choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area. | CVI was assessed 1 month after surgery. | 
| CVI at 3 months postoperatively | choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area. | CVI was assessed 3 months after surgery. | 
| CT at baseline | Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device. | CT was assessed at baseline and 1 week, 1 month, 3 month after surgery. | 
| CT at 1 week postoperatively | Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device. | CT was assessed at 1 week after surgery. | 
| CT at 1 month postoperatively | Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device. | CT was assessed at 1 month after surgery. | 
| CT at 3 months postoperatively | Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device. | CT was assessed at 3 months after surgery. | 
| VD at baseline | VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid. | VD of the choriocapillaris was assessed at baseline. | 
| VD at 1 week postoperatively | VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid. | VD of the choriocapillaris was assessed 1 week after surgery. | 
| VD at 1 month postoperatively | VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid. | VD of the choriocapillaris was assessed 1 month after surgery. | 
| VD at 3 months postoperatively | VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid | VD of the choriocapillaris was assessed 3 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP at baseline | IOP was the value of intraocular pressure. | IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery. | 
| IOP at 1 week postoperatively | IOP was the value of intraocular pressure . | IOP was assessed 1 week after surgery. | 
| IOP at 1 month postoperatively | IOP was the value of intraocular pressure. | IOP was assessed 1 month after surgery. | 
| IOP at 3 months postoperatively | IOP was the value of intraocular pressure . | IOP was assessed 3 months after surgery. | 
| BCVA at baseline | BCVA was the best corrected visual acuity. | BCVA was assessed at baseline . | 
| BCVA at 3 months postoperatively | BCVA was the best corrected visual acuity. | BCVA was assessed 3 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic choroidopathy, Diabetic retinopathy, choroidal vascularity index, choroidal thickness