Clinical trial NCT03739255: Facilitation of Corneal Re-epithelialization After Photorefractive Keratectomy
Official title: Treatment of Postoperative Discomfort/Pain and Facilitation of Corneal Reepithelialization After Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Erosion
Lead sponsor: SynsLaser Kirurgi AS
Sponsor class: OTHER
Collaborators: name: Laboratoires Thea
First posted: 2018-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Photorefractive keratectomy (PRK) or surface ablation is one of the most commonly used surgical procedures to correct refractive errors, which was proved to be safe and effective. In PRK, the corneal epithelium is removed by various techniques such as diluted alcohol, manual debridement, brush, or excimer laser, before the refractive excimer laser ablation of the corneal stroma. Compared to laser in situ keratomileusis (LASIK), the two main drawbacks for PRK are slower visual recovery and discomfort in the immediate postoperative period, due to the epithelial removal.

Corneal healing is a complex process involving cellular interaction and reaction with various molecules (proteases, growth factors, and epithelial and stromal cytokines). Enhanced corneal re-epithelialization may reduce the risk for corneal infection and stromal scarring or melting. Over the past few years, a new type of matrix therapy by ReGeneraTing Agent (RGTA) has provided encouraging results, accelerating the healing of chronic skin ulcers in diabetes or vascular origin. RGTAs mimic the action of heparin sulfate molecules, breaking the negative repair-destruction cycle occurring in chronic lesions and inhibit proteolytic enzymes in vitro. In the domain of ophthalmology, RGTA has been reported to show encouraging results in the treatment of corneal ulcer and dystrophies of various etiologies.

The Cacicol20 is an RGTA that binds to matrix proteins to protect them from proteolysis; the extracellular matrix microenvironment protection improves the production of signals and growth factors needed for tissue healing. It is supplied as a sterile single-dose solution of alpha 1-6 poly-carboxymethyl glucose sulfate described and synthesized as in US Patent Number 6689741, with dextran T40 and 0.9% sodium chloride as excipients. It contains no component of animal or biological origin, and penetrates into the cornea without crossing Descemet´s membrane (no intraocular penetration). The Cacicol20 has been reported to be effective in treatment of neurotrophic ulcers and persistent epithelial defects which were unresponsive to the common treatment approaches. Therefore, we expect that the Cacicol20 may facilitate the corneal re-epithelialization after PRK.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing bilateral PRK surgeries for treatment of refractive error
* Age over 18 years
* Refractive stability for at least 2 years

Exclusion Criteria:

* Ocular pathology, including keratoconus or suspected keratoconus, glaucoma, and epithelial defects
* Previous corneal surgery
* Systemic disease that might affect corneal wound healing.

Primary outcomes:
measure: Re-epithelialization time
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: Discomfort during reepithelialization
timeFrame: 5 days postoperatively
Other outcomes:
measure: Postoperative corneal epithelial thickness
timeFrame: 1 week and 1 month postoperatively
measure: Inflammatory cytokine
timeFrame: Preoperatively, 24 hours and 72 hours after the surgery
measure: Postoperative uncorrected visual acuity
timeFrame: 1 week, 1 month postoperatively
measure: Refractive outcome
timeFrame: 1 month and 3 months postoperatively
measure: Protein expression in tear fluid
timeFrame: Preoperatively, 24 hours and 72 hours after the surgery
measure: Postoperative complications
timeFrame: 1 month and 3 months postoperatively
measure: Postoperative dry eye disease severity level
timeFrame: 1 month and 3 months postoperatively
Locations:
Study officials:
References:
citation: Groah SL, Libin A, Spungen M, Nguyen KL, Woods E, Nabili M, Ramella-Roman J, Barritault D. Regenerating matrix-based therapy for chronic wound healing: a prospective within-subject pilot study. Int Wound J. 2011 Feb;8(1):85-95. doi: 10.1111/j.1742-481X.2010.00748.x. Epub 2010 Nov 16.
citation: Garcia-Filipe S, Barbier-Chassefiere V, Alexakis C, Huet E, Ledoux D, Kerros ME, Petit E, Barritault D, Caruelle JP, Kern P. RGTA OTR4120, a heparan sulfate mimetic, is a possible long-term active agent to heal burned skin. J Biomed Mater Res A. 2007 Jan;80(1):75-84. doi: 10.1002/jbm.a.30874.
citation: Aifa A, Gueudry J, Portmann A, Delcampe A, Muraine M. Topical treatment with a new matrix therapy agent (RGTA) for the treatment of corneal neurotrophic ulcers. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8181-5. doi: 10.1167/iovs.12-10476.
citation: Kymionis GD, Liakopoulos DA, Grentzelos MA, Diakonis VF, Klados NE, Tsoulnaras KI, Tsilimbaris MK, Pallikaris IG. Combined topical application of a regenerative agent with a bandage contact lens for the treatment of persistent epithelial defects. Cornea. 2014 Aug;33(8):868-72. doi: 10.1097/ICO.0000000000000169.