- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04499768
A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy
August 4, 2020 updated by: Xi Shen, Ruijin Hospital
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200025
- Ruijin Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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control
the age-related cataract patients
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DR group
the cataract patients with mild/moderate NPDR
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CVI at baseline
Time Frame: 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.
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CVI was assessed at baseline(within 1 week before surgery)
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CVI at 1 week postoperatively
Time Frame: CVI was assessed 1 week after surgery.
|
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
Time Frame: CVI was assessed 1 month after surgery.
|
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
Time Frame: CVI was assessed 3 months after surgery.
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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
Time Frame: 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.
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CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
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CT at 1 week postoperatively
Time Frame: 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.
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CT was assessed at 1 week after surgery.
|
CT at 1 month postoperatively
Time Frame: 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.
|
CT was assessed at 1 month after surgery.
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CT at 3 months postoperatively
Time Frame: CT was assessed at 3 months after surgery.
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Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.
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CT was assessed at 3 months after surgery.
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VD at baseline
Time Frame: VD of the choriocapillaris was assessed at baseline.
|
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
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VD of the choriocapillaris was assessed at baseline.
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VD at 1 week postoperatively
Time Frame: VD of the choriocapillaris was assessed 1 week after surgery.
|
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
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VD of the choriocapillaris was assessed 1 week after surgery.
|
VD at 1 month postoperatively
Time Frame: VD of the choriocapillaris was assessed 1 month after surgery.
|
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
Time Frame: VD of the choriocapillaris was assessed 3 months after surgery.
|
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
Time Frame: IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
|
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
Time Frame: IOP was assessed 1 week after surgery.
|
IOP was the value of intraocular pressure .
|
IOP was assessed 1 week after surgery.
|
IOP at 1 month postoperatively
Time Frame: IOP was assessed 1 month after surgery.
|
IOP was the value of intraocular pressure.
|
IOP was assessed 1 month after surgery.
|
IOP at 3 months postoperatively
Time Frame: IOP was assessed 3 months after surgery.
|
IOP was the value of intraocular pressure .
|
IOP was assessed 3 months after surgery.
|
BCVA at baseline
Time Frame: BCVA was assessed at baseline .
|
BCVA was the best corrected visual acuity.
|
BCVA was assessed at baseline .
|
BCVA at 3 months postoperatively
Time Frame: BCVA was assessed 3 months after surgery.
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BCVA was the best corrected visual acuity.
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BCVA was assessed 3 months after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Xi Shen, PhD, Shanghai Jiao Tong University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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