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

Primary Purpose

Astigmatism

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
photorefractive keratectomy (PRK)
Sponsored by
Tabriz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Excimer Laser, photorefractive keratectomy, astigmatism

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nikookari eye hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cross-cylinder

single

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .
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.
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.
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

Full Information

First Posted
April 18, 2008
Last Updated
March 10, 2012
Sponsor
Tabriz University
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1. Study Identification

Unique Protocol Identification Number
NCT00663923
Brief Title
Comparison of Cross-cylinder and Conventional Photorefractive Keratectomy(PRK) in Correcting Medium-high Astigmatism
Acronym
PRK
Official Title
Comparison of Cross-cylinder and Conventional PRK for Laser Correction of Astigmatism: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tabriz University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Excimer Laser, photorefractive keratectomy, astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cross-cylinder
Arm Type
Experimental
Arm Description
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
Arm Title
single
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
photorefractive keratectomy (PRK)
Other Intervention Name(s)
photoastigmatic keratectomy
Intervention Description
comparison of PRK by cross-cylinder approach in one eye and conventional (single) method in the other eye for laser correction of astigmatism
Primary Outcome Measure Information:
Title
Correction of Astigmatism
Description
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.
Time Frame
six months after surgery
Secondary Outcome Measure Information:
Title
Higher Order Aberrations
Description
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 .
Time Frame
six months postoperative
Title
Corrected Distance Visual Acuity(CDVA)
Description
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.
Time Frame
six months
Title
Uncorrected Distance Visual Acuity (UCDVA)
Description
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.
Time Frame
six months
Title
Surgically Induced Astigmatism
Description
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
Time Frame
six months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad R Sedghipoor, MD
Organizational Affiliation
Ophthalmology Department, Tabriz University of medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Nikookari eye hospital
City
Tabriz
State/Province
East Azarbaijan
ZIP/Postal Code
5154645395
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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