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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04499768
Other study ID # 2018ZY14
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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.
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