Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
1 other identifier
observational
120
1 country
1
Brief Summary
This study aims to compare the retinal perfusion between diabetic and non-diabetic patients with Optical Coherence Tomography（OCT） Angiography after cataract surgery, to thoroughly evaluate the retinal state of diabetics after surgery, and to find out the relationship between postoperative complications occurred in retina and diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 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
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMay 3, 2022
May 1, 2022
2.3 years
March 26, 2019
May 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OCT Angiography parameters
comparison of vessel density in superficial and deep layers of retina between diabetic and non-diabetic patients with OCT Angiography.
3 months postoperatively
Secondary Outcomes (1)
aqueous humor cytokines levels
intraoperatively.
Study Arms (2)
diabetic patients after cataract surgery
diabetic patients after cataract surgery
non-diabetic patients after cataract surgery
non-diabetic patients after cataract surgery
Eligibility Criteria
Study Population: Asian
You may qualify if:
- Patients with age-related cataract and with willing to improve visual acuity by undergoing phacoemulsification and intraocular lens implantation surgery.
- Type 2 diabetes diagnosis according to American Diabetes Association# Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
- Willing to sign the consent form.
You may not qualify if:
- having known maculopathy, proliferative diabetic retinopathy(PDR), diabetic macular edema.
- with high myopia of spherical equivalent greater than -6.0 diopters or axial length (AXL) greater than 26 mm in either eye.
- preexisting vein or artery occlusion,glaucoma, previous uveitis, a history of ocular trauma, laser treatment, intravitreal injections or intraocular surgeries.
- patients who had complications during cataract surgery.
- Elimination Criteria:
- poor compliance
- voluntary withdrawal
- any other kind of situation that researchers consider not suitable for further study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Biospecimen
aqueous humor from the subjects
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hong Qi, MD
Peking University Third Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2019
First Posted
April 4, 2019
Study Start
September 1, 2018
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
May 3, 2022
Record last verified: 2022-05