Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery

NCT ID: NCT04660006

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-27

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract Diabetic Retinopathy Macular Edema Due to Diabetes Mellitus

Keywords

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Optical Coherence Tomography Angiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Patients undergoing uneventful cataract surgery with no retinal vascular disease.

Cataract surgery

Intervention Type PROCEDURE

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.

Cataract surgery

Intervention Type PROCEDURE

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.

Cataract surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uptown Eye Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah H Chiu, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Uptown Eye Specialists

Locations

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Uptown Eye Speicialists

Brampton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20827486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30278057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29705010 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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OCTa Study 1.0

Identifier Type: -

Identifier Source: org_study_id