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NCT03361709: DIABEDEX
Effect of Intracameral Dexamethasone After Phacoemulsification in Diabetics on Corneal Endothelial Cell Density
Phase 4 trial testing Dexamethasone in Diabetes Mellitus. Withdrawn.
1 June 2018
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 1 January 2018 |
| Primary completion | 1 June 2018 |
| Estimated completion | 1 July 2018 |
Drugs / interventions tested
- Dexamethasone (dexamethasone) — full drug profile →
- Saline Solutions, Intraocular — full drug profile →
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Corneal Endothelial Cell Loss — all drugs for Corneal Endothelial Cell Loss →
- Dexamethasone Adverse Reaction — all drugs for Dexamethasone Adverse Reaction →
- Corneal Endothelial Decompensation — all drugs for Corneal Endothelial Decompensation →
Sponsor
Cairo University
Who can join
40 and older, any sex, with Diabetes Mellitus or Corneal Endothelial Cell Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The prevalence of diabetes mellitus (DM) is rapidly growing worldwide. One major concern with diabetes mellitus is how it may affect vision in different ways; including the increased risk of developing cataract. Several studies have found an association between diabetes mellitus and the development of cataract. In patients with DM, cataract progression is also faster and occurs at a younger age.5 While results for modern cataract surgery are satisfactory, cataract surgery in diabetic patients carries a higher risk of peri and post-operative complications than in non-diabetic patients. Several studies have shown that the corneal endothelial count of diabetic patients is decreased, with more damage occurring to corneal endothelial cells following phacoemulsification in diabetics than in non-diabetics. This is presumed to be due to increased vulnerability of corneal endothelial cells in diabetics and a delay in the repair process. Administration of topical corticosteroids is the main method to control post-operative inflammation after phacoemulsification, however many studies have also proved the safety and efficacy of intracameral corticosteroids to control inflammation post-operatively. While intracameral triamcinolone is effective in controlling post-operative inflammation, elevation of intraocular pressure is a main concern. Dexamethasone has been found to be effective in controlling post-operative inflammation with no effect on intraocular pressure. This may be due to its rapid turnover and short half-life. No studies however have been performed to evaluate the safety and benefit of intracameral injection of dexamethasone following phacoemulsification in diabetic patients. In the present study, investigators aim to evaluate this and determine its effect on the post-operative corneal endothelial cell density and corneal thickness.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03361709
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Other Cairo University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03361709 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 24 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03361709.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing