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
Verified date | August 2020 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery
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. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
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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