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

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy; Optical Coherence Tomography; 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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control; the age-related cataract patients
DR group; the cataract patients with mild/moderate NPDR

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Xi Shen, PhD, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Yao H, Gao S, Liu X, Zhou Y, Cheng Y, Shen X. Choroidal Structural Changes Assessed with Swept-Source Optical Coherence Tomography after Cataract Surgery in Eyes with Diabetic Retinopathy. J Ophthalmol. 2020 Oct 29;2020:5839837. doi: 10.1155/2020/5839837. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Diabetic retinopathy; choroidal thickness; Diabetic choroidopathy; choroidal vascularity index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Lens Diseases; Retinal Diseases; Diabetic Retinopathy; Cataract; Capsule Opacification
• Other Study ID Numbers: 2018ZY14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No