CataractNCT04660006
Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery
An observational study of Cataract and Diabetic Retinopathy, run by Uptown Eye Specialists at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract, Diabetic Retinopathy, Macular Edema Due to Diabetes Mellitus
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2019to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants selected from Uptown Eye Specialists, an eye care clinic, at two sites in Brampton, Ontario, Canada and Vaughan, Ontario, Canada.
Who may be able to join
- All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Cataract surgery
- Keywords
- Optical Coherence Tomography Angiography
- Medical subject headings
- Cataract, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients undergoing uneventful cataract surgery with no retinal vascular disease. Receives: 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. Receives: 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. Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Secondary outcomes (1)
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.
Measured: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start27 May 2019
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uptown Eye Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah H Chiu, MD, FRCSC, Principal investigator, Uptown Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660006
- Sponsor's protocol ID
- OCTa Study 1.0
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20827486Yu 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.
PubMed 30278057Zhao 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.
PubMed 29705010Sorour 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 at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Changes Post-cataract Surgery in Patients With and Without Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04660006
- Acronym / sponsor ID
- OCTa Study 1.0
- Keywords
- Optical Coherence Tomography Angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Uptown Eye SpecialistsUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: Cataract surgeryPatients undergoing uneventful cataract surgery with no retinal vascular disease. |
| Diabetic Retinopathy (DR) | – | Procedure: Cataract surgeryPatients with non-proliferative diabetic retinopathy with no diabetic macular edema treatment in the 6 months prior to uneventful cataract surgery. |
| Diabetic Macular Edema (DME) | – | Procedure: Cataract surgeryPatients with diabetic macular edema undergoing active Anti-VEGF treatment (within the last 3 months) undergoing uneventful cataract surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants selected from Uptown Eye Specialists, an eye care clinic, at two sites in Brampton, Ontario, Canada and Vaughan, Ontario, Canada.
Key inclusion criteria (1 listed)
- All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryPatients 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. | Procedure or surgery | Control, Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Development of new cystoid macular edema
Time frame: Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Background: PubMed 20827486Eriksson 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.
- Background: PubMed 30278057Yu 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.
- Background: PubMed 29705010Zhao 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.
- BackgroundSorour O, Arya M, Waheed N. New findings and challenges in OCT angiography for diabetic retinopathy. Annals of Eye Science. 2018; 3(8): 44-54.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah H Chiu, MD, FRCSC principal investigator
Uptown Eye Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Diabetic Retinopathy, run by Uptown Eye Specialists at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04660006, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.