A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy

Purpose. An open-label pilot study of virgin coconut oil (VCO) was conducted to determine the safety of the agent as ocular rewetting eye drops on rabbits.Methods. Efficacy of the VCO was assessed by measuring NIBUT, anterior eye assessment, corneal staining, pH, and Schirmer value before instillation and at 30 min, 60 min, and two weeks after instillation. Friedman test was used to analyse any changes in all the measurable variables over the period of time.Results. Only conjunctival redness with instillation of saline agent showed significant difference over the period of time (P<0.05). However, further statistical analysis had shown no significant difference at 30 min, 60 min, and two weeks compared to initial measurement (P>0.05). There were no changes in the NIBUT, limbal redness, palpebral conjunctiva redness, corneal staining, pH, and Schirmer value over the period of time for each agent (P>0.05).Conclusion. VCO acts as safe rewetting eye drops as it has shown no significant difference in the measurable parameter compared to commercial brand eye drops and saline. These study data suggest that VCO is safe to be used as ocular rewetting agent on human being.

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NGF eye-drops topical administration in patients with retinitis pigmentosa, a pilot study

Journal of Translational Medicine ◽

10.1186/s12967-015-0750-3 ◽

2016 ◽

Vol 14 (1) ◽

Cited By ~ 20

Author(s):

Benedetto Falsini ◽

Giancarlo Iarossi ◽

Antonio Chiaretti ◽

Antonio Ruggiero ◽

Luigi Manni ◽

...

Keyword(s):

Pilot Study ◽

Retinitis Pigmentosa ◽

Topical Administration ◽

Eye Drops

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Dropless penetrating keratoplasty using a subconjunctival dexamethasone implant: safety pilot study

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2021-319376 ◽

2021 ◽

pp. bjophthalmol-2021-319376

Author(s):

Marie Caroline Trone ◽

Sylvain Poinard ◽

Emmanuel Crouzet ◽

Thibaud Garcin ◽

Marielle Mentek ◽

...

Keyword(s):

Pilot Study ◽

Penetrating Keratoplasty ◽

Corneal Thickness ◽

Rabbit Model ◽

Eye Drops ◽

Dexamethasone Implant ◽

Link Type ◽

Registration Number ◽

Discontinuous Nature ◽

Safety Monitoring Committee

Background/aimRejection is the main cause of graft failure after penetrating keratoplasty (PK). Its prevention by repeated instillation of steroid eye-drops has not evolved in decades. Poor adherence and discontinuous nature of eye-drop treatment may explain some PK failures. In a rabbit model, we previously demonstrated that a subconjunctival dexamethasone implant was well tolerated and prevented rejection efficiently in the first 5–6 weeks. This clinical trial investigates its tolerance and safety after PK.MethodsSingle-centre, phase II non-randomised tolerance and safety pilot study (NCT02834260). Designed to analyse the risk of elevated intraocular pressure (IOP), discomfort and resorption time. Fourteen patients with a low rejection risk indication of PK were enrolled between January 2017 and August 2018. The implant was injected in the 12 o’clock position, 5 mm from the limbus, at the end of PK. A steroid eye-drop treatment was planned when implant resorption was complete. Patients were monitored regularly for 12 months: IOP (main outcome measure at 1 month), discomfort and redness scores, implant status, rejection episode and central corneal thickness by optical coherence tomography. An independent data safety monitoring committee verified safety aspects.ResultsNo increase in IOP or other adverse event related to the implant was observed. Average resorption time was 6 weeks. The switch to steroid eye-drops was uneventful. One patient, included despite preoperative corneal neovascularisation (unintended protocol deviation) experienced a rejection.ConclusionsThis is the first proof of concept that dropless immunosuppression is possible after low rejection risk PK.Trial registration numberNCT02834260.

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