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Trial registered on ANZCTR


Registration number
ACTRN12612000438853
Ethics application status
Approved
Date submitted
13/04/2012
Date registered
18/04/2012
Date last updated
18/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes of intraocular pressure after photorefractive keratectomy; a comparison between Goldmann applanation tonometry and dynamic contour tonometry
Scientific title
A prospective clinical trial to compare changes of intraocular pressure after photorefractive keratectomy obtained by Goldmann applanation tonometry and dynamic contour tonometry
Secondary ID [1] 280327 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myopia 286288 0
myopic astigmatism 286289 0
Condition category
Condition code
Eye 286523 286523 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-Photorefractive keratectomy: All the participants underwent this operation using the Planoscan method of the Technolas 217z laser platform (Bausch & Lomb, USA) with an optical zone diameter of 6.00 mm, repetition rate of 50 Hz and a flat top-beam profile with spot size of 2.00 mm. After prep and drep (i.e. disinfecting the eyelids and periocular area for 1 minute with povidone–iodine 10% solution, and having the eyes washed out with 20 mL of a balanced salt solution), the epithelium was removed with a hockey knife and photoablation performed.
2-Goldmann applanation tonometry: The procedure was performed according to the guidelines of the Eye Care Technology Forum. The tear film was stained by placing paper fluorescein strips in the lower conjunctival fornix. Goldmann applanation tonometer (AT 900, HS Inc., USA) was mounted on a slit lamp (YJ-5Z, OcuHealth Plus Inc, New York, USA) and its tonometer was calibrated according to the manufacture’s instructions. The tonometer tip was brought into contact with the corneal surface and the intraocular pressure was documented after applanating the corneal surface and adjusting knob of the tonometer. Measurements were repeated 3 times at 30 second intervals and the readings averaged. Before each reading, the measuring drum was reset to approximately 2 mm Hg. In the case of fluctuation of IOP during the cardiac pulse cycle, it was measured in the middle of the pulsation amplitude.
3-Dynamic contour tonometry: Dynamic contour tonometer (Pascal, Swiss Micro Technology, Switzerland) was mounted on the same slit-lamp and IOP measurement was accomplished according to the manufactures’ guidelines. The tonometer tip of this device, similar to that of the GAT, contacts the corneal surface. However, its correct positioning is indicated by an audible signal that changes in pitch with changes in the pressure detected. IOP measurement with DCT was repeated if the quality score was greater than 2.
In all participants, Goldmann applanation tonometry was performed 5 minutes after Dynamic contour tonometry on the same day.
Intervention code [1] 284681 0
Early detection / Screening
Comparator / control treatment
active control
standard treatment including photorefractive keratectomy as described before. In eyes in which the ablation depth was greater than 50 micro m, mitomycin-C 0.02% (0.2 mg/mL) was applied for up to 25 seconds. Then the eyes were irrigated with 50 mL of a balanced salt solution and bandage contact lenses were fitted. Postoperatively, ciprofloxacin 0.3% eye drop (Ciplox, Cipla, Mumbai, India) and betamethasone 0.1% eye drop (CIBA VISION, USA) were administered 3 times/day until complete corneal reepithelialization was ensured. Betamethasone 0.1% eye drops were administered 4 times/day for 1 month and then tapered over the next month.
Control group
Active

Outcomes
Primary outcome [1] 286955 0
intraocular pressure by Goldmann applanation tonometry and dynamic contour tonometry
Timepoint [1] 286955 0
before and 6 months after operation
Secondary outcome [1] 297053 0
central corneal thickness by ultrasonic pachymetry
Timepoint [1] 297053 0
before and 6 months after operation

Eligibility
Key inclusion criteria
candidates for bilateral PRK to correct myopia or myopic astigmatism without any history of ocular trauma/surgery or corneal disease
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of ocular trauma/surgery or corneal disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4260 0
Iran, Islamic Republic Of
State/province [1] 4260 0
Tehran

Funding & Sponsors
Funding source category [1] 285098 0
Self funded/Unfunded
Name [1] 285098 0
Afshin Lotfi Sedigh
Address [1] 285098 0
Sheshkelan Ave., Nikookari Hospital, Tabriz, PO BOX:45395-51546
Country [1] 285098 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Afshin Lotfi Sedigh
Address
Sheshkelan Ave., Nikookari Hospital, Tabriz, PO BOX:45395-51546
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 283958 0
Individual
Name [1] 283958 0
Hassan Hashemi
Address [1] 283958 0
Valiasr Ave., Zafar, Esfandiar Bulvar, Noor Ophthalmology Research Center, Tehran, Iran, PO Box: 19395-3475
Country [1] 283958 0
Iran, Islamic Republic Of
Secondary sponsor category [2] 283959 0
None
Name [2] 283959 0
Address [2] 283959 0
Country [2] 283959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287113 0
Tehran University of Medical Sciences
Ethics committee address [1] 287113 0
Ethics committee country [1] 287113 0
Date submitted for ethics approval [1] 287113 0
Approval date [1] 287113 0
Ethics approval number [1] 287113 0

Summary
Brief summary
The main objective of this prospective study was to compare intraocular oressure changes before and at 6 months after photorefractive keratectomy (PRK) obtained by Goldmann applanation tonometry and dynamic contour tonometryin patients with myopia or myopic astigmatism in relation to changes of central corneal thickness, as well as to suggest a correcting formula, if applicable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34066 0
Address 34066 0
Country 34066 0
Phone 34066 0
Fax 34066 0
Email 34066 0
Contact person for public queries
Name 17313 0
Rohollah F Fouladi
Address 17313 0
Golgasht Ave., University of Medical Sciences, Medical Faculty, Tabriz, PO BOX: 51655-118
Country 17313 0
Iran, Islamic Republic Of
Phone 17313 0
+989144122542
Fax 17313 0
Email 17313 0
medicorelax@yahoo.com
Contact person for scientific queries
Name 8241 0
Rohollah F Fouladi
Address 8241 0
Golgasht Ave., University of Medical Sciences, Medical Faculty, Tabriz, PO BOX: 51655-118
Country 8241 0
Iran, Islamic Republic Of
Phone 8241 0
+989144122542
Fax 8241 0
Email 8241 0
medicorelax@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary