Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes. (NCT05413330) | Clinical Trial Compass
CompletedPhase 2/3
Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
Syria73 participantsStarted 2020-09-12
Plain-language summary
The investigators aim in this study to investigate the effect of intravitreal triamcinolone acetonide injection on the development of macular edema and the progression of diabetic retinopathy. Whether this injection hastens cataract surgery results or not. The investigators will categorize the participants into two groups: the case group who will receive the injection at the end of the surgery, and the control group who will have routine cataract surgery with no extra injections.
Who can participate
Age range
19 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ● A history of diabetes mellitus DM type II that is well-confirmed by an endocrinologist.
* Senile cataract that is causing visual disturbance as demonstrated by clinical examination.
* CDVA of no more than 20/ 40, finger count and hand movement vision are included. Too.
* Diabetic retinopathy that falls in one of the following categories according to the International Clinical Diabetic Retinopathy Disease Severity Scale: No DR- mild NPDR- moderate NPDR.
* A healthy-looking central macula, or Clinically Significant Macular Edema (CSME), or edema that is apparent on Fundus Fluorescent Angiography (FFA) or OCT, as well as a treatment-resistant diabetic macular edema in the past 24 months or microaneurysms at foveal avascular zone (FAZ) borders not amenable to laser therapy.
* Both sexes, Age 18 years or older.
* One eye per patient will be included.
* The surgery will be performed by the same surgeon and the samIOL design will be used.
Exclusion Criteria:
* • A history of diabetes mellitus DM type I that is well-confirmed by an endocrinologist or no history of DM.
* CDVA that is better than 20/40.
* functionally monocular patient as a result of moderate to severe visual impairment in the contralateral eye, as per the definition of the International Statistical Classification of Diseases and Related Health Problems, 10th revision (6).
* The presence of pathologies other than diabetic retinopathy and cataract that may justify visual …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in central subfield mean macular thickness as a measurement of efficacy