Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery

NCT04660006 | Unknown

• 1 other identifier: OCTa Study 1.0
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract; Diabetic Retinopathy; Macular Edema Due to Diabetes Mellitus

Keywords

Optical Coherence Tomography Angiography

Outcome Measures

Primary Outcomes (4)

• Change from baseline of retinal vessel density up to 3 months post-cataract surgery.

  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.

  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.

  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.

  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 Outcomes (1)

• Development of new cystoid macular edema

  Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)

Study Arms (3)

Control

Patients undergoing uneventful cataract surgery with no retinal vascular disease.

Procedure: Cataract surgery

Diabetic Retinopathy (DR)

Patients with non-proliferative diabetic retinopathy with no diabetic macular edema treatment in the 6 months prior to uneventful cataract surgery.

Procedure: Cataract surgery

Diabetic Macular Edema (DME)

Patients with diabetic macular edema undergoing active Anti-VEGF treatment (within the last 3 months) undergoing uneventful cataract surgery.

Procedure: Cataract surgery

Interventions

Cataract surgery 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.

Control; Diabetic Macular Edema (DME); Diabetic Retinopathy (DR)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uptown Eye Specialists: lead

Study Sites (1)

Uptown Eye Speicialists

Brampton, Ontario, L6Y0P6, Canada

Location

Related Publications (4)

• 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.

  PMID: 20827486 BACKGROUND

• 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.

  PMID: 30278057 BACKGROUND

• 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.

  PMID: 29705010 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cataract; Diabetic Retinopathy

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hannah H Chiu, MD, FRCSC

  Uptown Eye Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: May 27, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)