A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy
1 other identifier
observational
46
1 country
1
Brief Summary
To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedFirst Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedAugust 5, 2020
August 1, 2020
1.4 years
July 30, 2020
August 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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 Outcomes (6)
IOP at baseline
IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
IOP at 1 week postoperatively
IOP was assessed 1 week after surgery.
IOP at 1 month postoperatively
IOP was assessed 1 month after surgery.
IOP at 3 months postoperatively
IOP was assessed 3 months after surgery.
BCVA at baseline
BCVA was assessed at baseline .
- +1 more secondary outcomes
Study Arms (2)
control
the age-related cataract patients
DR group
the cataract patients with mild/moderate NPDR
Eligibility Criteria
23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients
You may qualify if:
- aged⩾40years; intraocular pressure (IOP) \< 21 mm Hg in both eyes, spherical refractive error\<6 diopters spherical equivalent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
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.
PMID: 33178452DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xi Shen, PhD
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 5, 2020
Study Start
June 1, 2018
Primary Completion
October 30, 2019
Study Completion
December 30, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08