Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery

Cataract Clinical Trial

Official title:

Optical Coherence Tomography Angiography Changes Post-cataract Surgery in Patients With and Without Diabetic Retinopathy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04660006
• Other study ID #: OCTa Study 1.0
• Status: Enrolling by invitation
• Start date: May 27, 2019
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: Uptown Eye Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 170
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Diabetic Retinopathy
• Macular Edema
• Macular Edema Due to Diabetes Mellitus
• Retinal Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	Uptown Eye Speicialists	Brampton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Uptown Eye Specialists

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Eriksson U, Alm A, Bjärnhall 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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Development of new cystoid macular edema	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)