Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery
December 2, 2020 updated by: Uptown Eye Specialists
Optical Coherence Tomography Angiography Changes Post-cataract Surgery in Patients With and Without Diabetic Retinopathy
The purpose of this study is to use optical coherence tomography angiography (OCT-A) to compare retinal vasculature after uncomplicated cataract surgery in patients with and without diabetic retinopathy.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Patients undergoing cataract surgery who provided informed consent were enrolled in the study.
There were three comparison groups: control, diabetic retinopathy (DR) and diabetic macular edema (DME) groups.
Optical coherence tomography angiography (OCT-A) scans measuring retinal thickness, vessel density, perfusion density, and foveal avascular zone were obtained at baseline and postoperative week one, month one and month three.
Study Type
Observational
Enrollment (Anticipated)
170
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
-
-
Ontario
-
Brampton, Ontario, Canada, L6Y0P6
- Uptown Eye Speicialists
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants selected from Uptown Eye Specialists, an eye care clinic, at two sites in Brampton, Ontario, Canada and Vaughan, Ontario, Canada.
Description
Inclusion Criteria:
- All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study.
Exclusion Criteria:
- Other ocular co-morbidities such as axial length < 22.0 mm or > 25.0 mm, previous ocular surgeries, previous history of uveitis, previous ocular trauma, cornea pathologies or glaucoma, intraocular pressures over 22 mmHg
- In groups 1 and 2: previous retinal laser treatments
- OCT-A signal strength < 6
- Use of multifocal intraocular lens
- Second eye (if first eye recruited)
- In Group 1: No diabetes mellitus as past medical history
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
Patients undergoing uneventful cataract surgery with no retinal vascular disease.
|
Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups.
Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.
|
|
Diabetic Retinopathy (DR)
Patients with non-proliferative diabetic retinopathy with no diabetic macular edema treatment in the 6 months prior to uneventful cataract surgery.
|
Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups.
Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.
|
|
Diabetic Macular Edema (DME)
Patients with diabetic macular edema undergoing active Anti-VEGF treatment (within the last 3 months) undergoing uneventful cataract surgery.
|
Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups.
Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline of retinal vessel density up to 3 months post-cataract surgery.
Time Frame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three.
This imaging modality provides measurements for retinal vessel density to be compared between groups and time.
|
Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
|
Change from baseline of retinal perfusion density up to 3 months post-cataract surgery.
Time Frame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three.
This imaging modality provides measurements for retinal perfusion density to be compared between groups and time.
|
Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
|
Change from baseline of foveal avascular zone up to 3 months post-cataract surgery.
Time Frame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three.
This imaging modality provides measurements for foveal avascular zone (FAZ), particularly FAZ area, perimeter, and circularity index, to be compared between groups and time.
|
Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
|
Change from baseline of retinal thickness up to 3 months post-cataract surgery.
Time Frame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
Optical coherence tomography (OCT) scans will be taken at baseline and postoperative week one, month one, and month three.
This imaging modality provides measurements of retinal thickness, particularly, central subfield and average macular cube thickness, to be compared between groups and time.
|
Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of new cystoid macular edema
Time Frame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
|
New cases of cystoid macular edema (a potential side effect of cataract surgery) are to be recorded to determine if there are preoperative risk factors for development of cystoid macular edema post-cataract surgery.
|
Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hannah H Chiu, MD, FRCSC, Uptown Eye Specialists
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.
General Publications
- Eriksson U, Alm A, Bjarnhall G, Granstam E, Matsson AW. Macular edema and visual outcome following cataract surgery in patients with diabetic retinopathy and controls. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):349-59. doi: 10.1007/s00417-010-1484-9. Epub 2010 Sep 9.
- Yu S, Frueh BE, Steinmair D, Ebneter A, Wolf S, Zinkernagel MS, Munk MR. Cataract significantly influences quantitative measurements on swept-source optical coherence tomography angiography imaging. PLoS One. 2018 Oct 2;13(10):e0204501. doi: 10.1371/journal.pone.0204501. eCollection 2018.
- Zhao Z, Wen W, Jiang C, Lu Y. Changes in macular vasculature after uncomplicated phacoemulsification surgery: Optical coherence tomography angiography study. J Cataract Refract Surg. 2018 Apr;44(4):453-458. doi: 10.1016/j.jcrs.2018.02.014. Epub 2018 Apr 25.
- Sorour O, Arya M, Waheed N. New findings and challenges in OCT angiography for diabetic retinopathy. Annals of Eye Science. 2018; 3(8): 44-54.
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)
May 27, 2019
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 9, 2020
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 2, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCTa Study 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.