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

Phase 3

Completed

Conditions: Astigmatism

Interventions: Procedure: photorefractive keratectomy (PRK)

Registration Number: NCT00663923

Lead Sponsor: Tabriz University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cross-cylinder	photorefractive keratectomy (PRK)	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
single	photorefractive keratectomy (PRK)	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.

Primary Outcome Measures

Name	Time	Method
Correction of Astigmatism	six months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Higher Order Aberrations	six months postoperative	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 .
Corrected Distance Visual Acuity(CDVA)	six months	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.
Uncorrected Distance Visual Acuity (UCDVA)	six months	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.
Surgically Induced Astigmatism	six months after surgery	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