Comparison of Cross-cylinder and Conventional Photorefractive Keratectomy(PRK) in Correcting Medium-high Astigmatism

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cross-cylinder approach is more effective than routine method in laser correction of astigmatism.

Detailed Description
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Both eyes of 50 patients(100 eyes) with medium-high compound myopic astigmatism and inclusion criteria,will be treated by photorefractive keratectomy (PRK) using excimer laser.It breaks chemical bonds within corneal stroma.It's wavelength is 193 nm that is in the ultraviolets range with high energy and very low tissue penetrance. The right or left eye of every patient would be allocated randomly to one of the study groups using RandList 1.1. In spite of recent advances in excimer laser machines and surgical techniques,correction of astigmatism is not more successful compared to myopia. In this study we will compare two methods of laser correction of astigmatism regarding to visual acuity,residual error and aberrations.

Official Title
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Comparison of Cross-cylinder and Conventional PRK for Laser Correction of Astigmatism: A Randomized Clinical Trial.

Conditions
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Astigmatism

Intervention / Treatment
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* Procedure: photorefractive keratectomy (PRK)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >20 years of age refractive stability for at least one year regular and symmetric astigmatism of >1.5 diopters Exclusion Criteria: corneal thickness<470 microns keratoconus or suspected keratoconus active ocular disease and systemic collagen disease

Ages Eligible for Study
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Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cross-cylinder<br>In this technique the laser is programmed with the axis and amount of cylinder,so that the steepest meridian is flattened with central cylindrical ablation and the flattest meridian steepens with paracentral ablation | Procedure: photorefractive keratectomy (PRK)<br>* comparison of PRK by cross-cylinder approach in one eye and conventional (single) method in the other eye for laser correction of astigmatism<br>* Other names: photoastigmatic keratectomy;|
| Active Comparator: single<br>In this technique ,cylinder is treated only on one meridian by performing an elliptical ablation to to flatten the steeper meridian to match the flatter meridian. | Procedure: photorefractive keratectomy (PRK)<br>* comparison of PRK by cross-cylinder approach in one eye and conventional (single) method in the other eye for laser correction of astigmatism<br>* Other names: photoastigmatic keratectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correction of Astigmatism | It shows the result of correction of astigmatism .In compound myopic astigmatism the meridians of maximum and minimum power are both too strong.So both line images fall short of the retina.It is measured by refraction(using autorefractor).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters. | six months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher Order Aberrations | Although lower- order aberrations decrease after laser vision correction,higher -order aberrations may increase after conventional PRK or LASIK(Laser in situ keratomileusis).Higher-order aberration is Composed of delicate irregularities within the cornea not correctable by spectacles.It is measured using aberrometer.In this study OPD scan was used that is one of the methods of wavefront analysis . | six months postoperative | 
| Corrected Distance Visual Acuity(CDVA) | CDVA is attained after correction of refractive errors using lenses of varying powers .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart(the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations. | six months | 
| Uncorrected Distance Visual Acuity (UCDVA) | UCDVA is attained without correction of refractive errors .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart( the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations. | six months | 
| Surgically Induced Astigmatism | It is the vector of the astigmatic change actually induced by the surgery.Participant population was the same as baseline participants. It was measured by refraction(using autorefractor) and vector analysis(using special software).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters | six months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excimer Laser, photorefractive keratectomy, astigmatism