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

• Conditions: Diabetic Retinopathy; Choroid; Optical Coherence Tomography

• Registration Number: NCT04499768
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

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 Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-10-30
• Study First Submitted: 2020-07-30
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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 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.
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.
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 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
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.
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.

Secondary Outcome Measures

Name	Time	Method
BCVA at 3 months postoperatively	BCVA was assessed 3 months after surgery.	BCVA was the best corrected visual acuity.
IOP at 1 week postoperatively	IOP was assessed 1 week 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.
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 month postoperatively	IOP was assessed 1 month after surgery.	IOP was the value of intraocular pressure.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China