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

Sponsor

Ruijin Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04499768

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Optical Coherence Tomography Diabetic Retinopathy Choroid

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

46 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Oct 30, 2019

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
control the age-related cataract patients
DR group the cataract patients with mild/moderate NPDR

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

IOP at baseline [IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.]
IOP was the value of intraocular pressure.
IOP at 1 week postoperatively [IOP was assessed 1 week after surgery.]
IOP was the value of intraocular pressure .
IOP at 1 month postoperatively [IOP was assessed 1 month after surgery.]
IOP was the value of intraocular pressure.
IOP at 3 months postoperatively [IOP was assessed 3 months after surgery.]
IOP was the value of intraocular pressure .
BCVA at baseline [BCVA was assessed at baseline .]
BCVA was the best corrected visual acuity.
BCVA at 3 months postoperatively [BCVA was assessed 3 months after surgery.]
BCVA was the best corrected visual acuity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

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.