Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)

Study Overview
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Brief Summary
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This study sets out to evaluate the EpiMaster application software for use in predicting the refractive change induced by a trans-epithelial phototherapeutic keratectomy (TE-PTK) procedure in eyes with irregularly irregular astigmatism. If validation criteria are met during the observational phase, the software refractive prediction will be used to plan the refractive correction in TE-PTK treatments.

Detailed Description
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Complications after laser eye surgery can often result in the front surface of the eye (the cornea) becoming irregular, which causes visual symptoms such as halos, glare, starbursts, double vision, and reduced contrast sensitivity. For the past 20 years, corneal irregularities have been treated using wavefront-guided ablation, topography-guided ablation or trans-epithelial phototherapeutic keratectomy (TE-PTK). Topography-guided ablation is the most effective treatment for certain types of irregularity and works by using a laser to remove tissue from the cornea in a pattern derived from a topography scan (a measurement of the shape and curvature of the front of the eye) designed to make the corneal surface more regular. However, topography-guided ablation is less effective for other types of irregularity. In these cases, the corneal epithelium (the layer of skin on the surface of the cornea) has changed in thickness to partially hide the irregularity on the body of the cornea under the epithelium (the stroma). The epithelium does this by becoming thinner over peaks and thickening over troughs in the stroma. Therefore, the topography measurement can only detect the proportion of the irregularity that has not been hidden by the epithelium, hence reducing its effectiveness. The preferred treatment option is TE-PTK; the laser treatment is applied onto and through the epithelium, breaking through to the stroma where the epithelium is thinnest, thus removing tissue from the peaks on the stroma resulting in a more regular surface. The main weakness of TE-PTK is that it may unpredictably change the refraction to become more short-sighted or more long-sighted or change the astigmatism. To improve this, we have developed the Epimaster software that simulates a TE-PTK treatment and predicts the change in refraction. The aim of the study is to validate the refractive prediction produced by the Epimaster software by comparing this to the achieved result in the patients treated. The treatment received by the patient will be the same as has been used routinely for the past 20 years.

Official Title
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Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)

Conditions
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Corneal Astigmatism

Intervention / Treatment
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* Procedure: Trans-epithelial PTK
* Device: EpiMaster Application Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presents with topographic irregularly irregular astigmatism and associated quality of vision issues, where TE-PTK would be a more effective treatment than topography-guided ablation or other therapeutic treatment options. Medically suitable for corneal laser refractive surgery. Calculated residual stromal thickness ≥250 µm. Subjects should be 21 years of age or older. Contact lens wearers must stop wearing their contact lenses one week per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses. Patient will be able to understand the patient information and willing to sign an informed consent. Patient will be willing to comply with all follow-up visits and the respective examinations. Exclusion Criteria: Patient not being able to tolerate local or topical anesthesia Autoimmune diseases Sicca syndrome, dry eye Herpes viral (herpes simplex) infections Herpes zoster Diabetes Pregnant or nursing women (or who are planning pregnancy during the study) Patients with a weight of > 135 kg Any residual, recurrent or acute ocular disease or abnormality of the eye, e.g. Cataract Suspected glaucoma or an intraocular pressure > 21 mm of Hg Corneal disease Corneal thinning disorder, e.g. keratoconus, Pellucid marginal corneal degeneration Dystrophy of the basal membrane Corneal oedema Exudative macular degeneration Infection Any residual, recurrent, or active abnormality of the cornea to be treated, e.g. Existing corneal implant Corneal lesion Unstable refraction Connective tissue disease Dry eye

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 1 will be observational comparing the software predicted refractive change to the observed refractive change. Phase 2 will use the software predicted refractive change to plan the refractive component of the treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observation Phase<br>A trans-epithelial PTK procedure will be performed using the MEL 90 excimer laser. The refractive outcome will be compared to the refractive change predicted by the EpiMaster application software. | Procedure: Trans-epithelial PTK<br>* The MEL 90 excimer laser will be used to ablate the corneal epithelium and stroma to a pre-defined depth, using the epithelium as a natural masking agent to smooth the stromal surface.<br>Device: EpiMaster Application Software<br>* The EpiMaster Application Software imports epithelial thickness data and corneal front surface topography data, and uses this to calculate the refractive change that would be induced by a trans-epithelial PTK treatment.<br>|
| Experimental: Treatment Phase<br>If the transition criteria are met during the observational phase, the treatment phase will be initiated. A trans-epithelial PTK procedure will be performed using the MEL 90 excimer laser, including a refractive component according to the values determined using the EpiMaster application software. | Procedure: Trans-epithelial PTK<br>* The MEL 90 excimer laser will be used to ablate the corneal epithelium and stroma to a pre-defined depth, using the epithelium as a natural masking agent to smooth the stromal surface.<br>Device: EpiMaster Application Software<br>* The EpiMaster Application Software imports epithelial thickness data and corneal front surface topography data, and uses this to calculate the refractive change that would be induced by a trans-epithelial PTK treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The tendency of manifest sphere, cylinder and axis | The correct tendency of manifest sphere, cylinder and axis should be achieved in 90% of cases, where tendency refers to: The sign of the predicted and the post-operative sphere is equal for predicted sphere values greater than absolute value 0.50 D (confidence limit) The sign of the predicted and the post-operative cylinder is equal (same cylinder format setting like e.g. plus cylinder format) for predicted cylinder values greater than absolute value 0.50 D (confidence limit) The cylinder axis of the predicted and the post-operative cylinder do not deviate by more than ±45° for predicted cylinder values greater than absolute value 0.50 D (confidence limit) In none of the cases the prediction in sphere and cylinder is more than absolute value 2.00 D off the post-operative values. | 3-12 months | 
| Standard deviation of SEpostop-SEpredicted | Standard deviation of SEpostop-SEpredicted at each follow-up time point (represents the scatter of the refractive outcome), where SEpredicted is the refractive outcome predicted by the EpiMaster application software. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trans-epithelial phototherapeutic keratectomy, PTK, TE-PTK, Corneal epithelium, Excimer laser