1. Home
  2. Approved trials
  3. » فارسی

Clinical results comparison of mechanical and transepithelial debridement in photorefractive keratectomy

Protocol summary

Summary
Photorefractive keratectomy (PRK) is a kind of refractive error surgery with a long history in refractive error corrections. There are several ways for epithelial debridement before stromal ablation. In this study, we compared clinical factors such as operation time, rate of re epithelialization, postoperative pain, refractive error, epithelial defect, intraocular pressure, contrast acuity, uncorrected and best corrected acuity in mechanical (m-PRK) and trans epithelial PRK (t-PRK). This comparative study included 80 eyes of 40 patients with myopia and mean age of 31.22+-8.7 (ranged from 20 to 55) years. After complete preoperative examinations, mechanical technique was done in one eye randomly and transepithelial technique in the contralateral eye. All postoperative clinical factors were measured and recorded in 6 months. The inclusion criteria was patients with myopia up to 8.00D and have trend for doing PRk, with normal corneal thickness, normal IOP, normal epithelium and endothelium, and… the exclusion criteria was patients with anterior or posterior segment pathology, progressive refractive error, keratoconus, history of any ocular surgery and…

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072930249N1
Registration date: 2017-09-22, 1396/06/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Javad Heravian Shandiz
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6722
Email address
heraviansj@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Grant
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical results comparison of mechanical and transepithelial debridement in photorefractive keratectomy
Public title
Clinical results comparison of mechanical and transepithelial debridement in photorefractive keratectomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
The inclusion criteria was patients with myopia up to 8.00D and have trend for doing PRk; with normal corneal thickness; normal IOP; normal epithelium and endothelium; clear medias; leaving wearing soft contact lenses for two weeks and hard contact lenses for three month; have normal tear quantity and quality; the exclusion criteria was patients with anterior or posterior segment pathology; progressive refractive error; keratoconus; history of any ocular surgery; amblyopia; dry eye
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical sciences
Street address
Department of Optometry, School of Paramedical Sciences
City
Mashhad
Postal code
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.MUMS.REC.1396.130

Health conditions studied

1

Description of health condition studied
Refractive surgery
ICD-10 code
H57.8
ICD-10 code description
Other specified disorders of eye and adnexa

Primary outcomes

1

Description
Postoperative pain assessment
Timepoint
The first, third, fifth and first, third and sixth months after surgery
Method of measurement
Using 11-point numeric scale of pain and eye sensation scale questionnaires

Secondary outcomes

1

Description
UCVA, refraction, BCVA, keratometry, bio microscopy, tear quantity, contrast acuity, IOP
Timepoint
The first, third and sixth months
Method of measurement
Visual acuity chart, auto refractometer, keratometer, slit lamp, schirmer test 1, Vector Vision CSV 1000, tonometer

Intervention groups

1

Description
PRK surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital in Mashhad
Full name of responsible person
Dr. Siamak Zarei
Street address
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Javad Heravian
Street address
Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical sciences
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Javad Heravian
Position
Professor and director of optometry department of Paramedical School
Other areas of specialty/work
Street address
University compound
City
mashhad
Postal code
Phone
+98 51338846722
Fax
Email
heraviansj@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Paramedical Sciences, Mashhad University of Medical sciences, Mashhad, Iran
Full name of responsible person
Professor Javad Heravian
Position
Professor of Optometry
Other areas of specialty/work
Street address
Ferdowsi University campus
City
mashhad
Postal code
Phone
+98 51338846722
Fax
Email
heraviansj@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Javad Heravian
Position
Professor and director of optometry department of Paramedical School
Other areas of specialty/work
Street address
Azadi Square - Campus University - Faculty of Paramedicine
City
mashhad
Postal code
Phone
+98 51338846722
Fax
Email
heraviansj@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...