Clinical trial NCT04660006: Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery
Official title: Optical Coherence Tomography Angiography Changes Post-cataract Surgery in Patients With and Without Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Diabetic Retinopathy
Macular Edema Due to Diabetes Mellitus
Keywords: Optical Coherence Tomography Angiography
Lead sponsor: Uptown Eye Specialists
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of retinal vessel density up to 3 months post-cataract surgery.
timeFrame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
measure: Change from baseline of retinal perfusion density up to 3 months post-cataract surgery.
timeFrame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
measure: Change from baseline of foveal avascular zone up to 3 months post-cataract surgery.
timeFrame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
measure: Change from baseline of retinal thickness up to 3 months post-cataract surgery.
timeFrame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Secondary outcomes:
measure: Development of new cystoid macular edema
timeFrame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Uptown Eye Speicialists
state: Ontario
Study officials:
affiliation: Uptown Eye Specialists
name: Hannah H Chiu, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.