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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04499768
• Other study ID #: 2018ZY14
• Status: Enrolling by invitation
• Start date: June 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 46
• Est. completion date: December 30, 2020
• Est. primary completion date: October 30, 2019
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Choroid
• Diabetic Retinopathy
• Optical Coherence Tomography
• Retinal Diseases

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	IOP at baseline	IOP was the value of intraocular pressure.	IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
Secondary	IOP at 1 week postoperatively	IOP was the value of intraocular pressure .	IOP was assessed 1 week after surgery.
Secondary	IOP at 1 month postoperatively	IOP was the value of intraocular pressure.	IOP was assessed 1 month after surgery.
Secondary	IOP at 3 months postoperatively	IOP was the value of intraocular pressure .	IOP was assessed 3 months after surgery.
Secondary	BCVA at baseline	BCVA was the best corrected visual acuity.	BCVA was assessed at baseline .
Secondary	BCVA at 3 months postoperatively	BCVA was the best corrected visual acuity.	BCVA was assessed 3 months after surgery.