NCT06159881 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hafezi F, Kling S, Gilardoni F, Hafezi N, Hillen M, Abrishamchi R, Gomes JAP, Mazzotta C, Randleman JB, Torres-Netto EA
Individualized Corneal Cross-linking With Riboflavin and UV-A in Ultrathin Corneas: The Sub400 Protocol. Am J Ophthalmol. 2021 Apr;224:133-142. doi: 10.1016/j.ajo.2020.12.011. Epub 2021 Jan 30.
Lang PZ, Hafezi NL, Khandelwal SS, Torres-Netto EA, Hafezi F, Randleman JB
Comparative Functional Outcomes After Corneal Crosslinking Using Standard, Accelerated, and Accelerated With Higher Total Fluence Protocols. Cornea. 2019 Apr;38(4):433-441. doi: 10.1097/ICO.0000000000001878.
Nath S, Shen C, Koziarz A, Banfield L, Nowrouzi-Kia B, Fava MA, Hodge WG
Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis. Ophthalmology. 2021 Aug;128(8):1150-1160. doi: 10.1016/j.ophtha.2020.12.023. Epub 2020 Dec 28.

Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus Corneas

Clinical trial NCT06159881 - References