Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
1 other identifier
observational
30
1 country
1
Brief Summary
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedDecember 5, 2023
December 1, 2023
9 months
October 13, 2020
December 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA
1 week after surgery
Study Arms (2)
Group(1): Cataract with no diabetic retinopathy
Group (2): Cataract associated with diabetic retinopathy
Interventions
Phacoemulsification for removal of cataract
Eligibility Criteria
This will be a prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital
You may qualify if:
- \- Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus
- Intraocular pressure (IOP) of 21 mm Hg or lower
- Axial length (AL) between 20.0 mm and 25.0 mm.
You may not qualify if:
- Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,
- IOP higher than 21 mm Hg,
- History of ocular trauma or intraocular surgery, or any abnormal intraocular findings
- Poor OCT-A images because of severe cataracts or unstable fixation
- Any signs of intraoperative or postoperative complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University Hospital
Tanta, El-Garbeia, 31515, Egypt
Related Publications (7)
Mirshahi A, Hohn F, Lorenz K, Hattenbach LO. Incidence of posterior vitreous detachment after cataract surgery. J Cataract Refract Surg. 2009 Jun;35(6):987-91. doi: 10.1016/j.jcrs.2009.02.016.
PMID: 19465281RESULTRipandelli G, Coppe AM, Parisi V, Olzi D, Scassa C, Chiaravalloti A, Stirpe M. Posterior vitreous detachment and retinal detachment after cataract surgery. Ophthalmology. 2007 Apr;114(4):692-7. doi: 10.1016/j.ophtha.2006.08.045. Epub 2007 Jan 17.
PMID: 17208303RESULTRossetti L, Autelitano A. Cystoid macular edema following cataract surgery. Curr Opin Ophthalmol. 2000 Feb;11(1):65-72. doi: 10.1097/00055735-200002000-00010.
PMID: 10724830RESULTFlach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557-634. No abstract available.
PMID: 10360304RESULTKim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.
PMID: 17275910RESULTOr C, Sabrosa AS, Sorour O, Arya M, Waheed N. Use of OCTA, FA, and Ultra-Widefield Imaging in Quantifying Retinal Ischemia: A Review. Asia Pac J Ophthalmol (Phila). 2018 Jan-Feb;7(1):46-51. doi: 10.22608/APO.201812. Epub 2018 Feb 13.
PMID: 29436208RESULTSorour OA, Sabrosa AS, Yasin Alibhai A, Arya M, Ishibazawa A, Witkin AJ, Baumal CR, Duker JS, Waheed NK. Optical coherence tomography angiography analysis of macular vessel density before and after anti-VEGF therapy in eyes with diabetic retinopathy. Int Ophthalmol. 2019 Oct;39(10):2361-2371. doi: 10.1007/s10792-019-01076-x. Epub 2019 May 22.
PMID: 31119505RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Ophthalmology, Tanta University, Egypt
Study Record Dates
First Submitted
October 13, 2020
First Posted
October 20, 2020
Study Start
April 13, 2021
Primary Completion
December 30, 2021
Study Completion
December 30, 2024
Last Updated
December 5, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 3 months
- Access Criteria
- Link