Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography
Maculopathy
1 other identifier
observational
30
1 country
2
Brief Summary
Investigators aimed to assess the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .
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 Mar 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJanuary 10, 2023
September 1, 2022
1 year
August 31, 2022
January 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Macular changes in diabetic patients after phacoemulsification
Invgatorsiest aimed to examine the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .
baseline
Study Arms (2)
Study group
Control group
Interventions
effect of non steroidal anti inflammatory drugs on macular changes
Eligibility Criteria
preoperatively ,Nonsteroidal anti inflammatory drugs was used for prophylaxis before surgery at the postoperative week 1 we gave the same medication to this group
You may qualify if:
- Controlled type 2 non proliferative diabetic retinopathy (NPDR) patients. Immature cataract which does not interfere with ocular imaging.
You may not qualify if:
- Patient with dense cataract or vitreous hemorrhage interfering with measurement of central macular thickness Chronic uveitis Any posterior segment pathology that could affect retinal thickness Patient with complicated cataract surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assuit University
Asyut, Egypt
Egypt
Asyut, Egypt
Related Publications (1)
Furino C, Boscia F, Niro A, D'Addario M, Grassi MO, Saglimbene V, Reibaldi M, Alessio G. DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard Phacoemulsification. Retina. 2021 May 1;41(5):1102-1109. doi: 10.1097/IAE.0000000000002974.
PMID: 32897932BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohamed T. Abd Elmonaiem, Prof
Assiut University
- STUDY DIRECTOR
Gamal El Dein R. Osman, Ass prof
Assiut University
- STUDY DIRECTOR
Momen M. Aly, Lecture
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 21, 2022
Study Start
March 1, 2023
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
January 10, 2023
Record last verified: 2022-09