Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000014752
Ethics application status
Approved
Date submitted
14/12/2012
Date registered
7/01/2013
Date last updated
7/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Red-Free Light for Measurement of Intraocular Pressure in Healthy Volunteers using Goldmann Applanation Tonometer without Fluorescein
Scientific title
Red-Free Light for Measurement of Intraocular Pressure in Healthy Volunteers using Goldmann Applanation Tonometer without Fluorescein
Secondary ID [1] 281688 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
measurement of intraocular pressure ,a new method 287976 0
intraocular pressure assessment 287977 0
Condition category
Condition code
Eye 288360 288360 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Five hundred eyes of 250 patients attending the Ophthalmology Outpatient, Suez Canal University Clinic were measured for intraocular pressure using the same Goldmann applanation tonometer mounted on Haag-Streit Slit Lamp, measurement first were done with red free light without Fluorescein then other measurements were done with cobalt blue light and topical Fluorescein on the same eyes . The measurement for one patient take place in one session and all measurements takes 15 minutes per patient.
Intervention code [1] 286224 0
Not applicable
Comparator / control treatment
the same group had two active intervention. the measurement with cobalt blue light and topical fluorescein is the control group.
Control group
Active

Outcomes
Primary outcome [1] 288526 0
The Mean Intraocular Pressure {IOP} was 15.23+/- 6.3 (SD) mm Hg using the red free light without Fluorescein while the mean was 15.78 +/- 6. 7 (SD) mm Hg using cobalt blue light and after application of Fluorescein in the conjunctival sac. On paired t test analysis, this difference was not significant.
Timepoint [1] 288526 0
two months
Secondary outcome [1] 300513 0
None
Timepoint [1] 300513 0
None

Eligibility
Key inclusion criteria
healthy persons attending ophthalmology outpatient clinic
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
patients with corneal pathology

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2011
Actual
3/11/2011
Date of last participant enrolment
Anticipated
4/01/2012
Actual
4/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4760 0
Egypt
State/province [1] 4760 0
ismailia

Funding & Sponsors
Funding source category [1] 286477 0
University
Name [1] 286477 0
Suez Canal University Hospital
Country [1] 286477 0
Egypt
Primary sponsor type
University
Name
suez canal university hospital
Address
Suez Canal University Hospital
4 km street
Ismailia
postcode 675
Country
Egypt
Secondary sponsor category [1] 285268 0
None
Name [1] 285268 0
Address [1] 285268 0
Country [1] 285268 0
Other collaborator category [1] 277228 0
None
Name [1] 277228 0
none
Address [1] 277228 0
none
Country [1] 277228 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288555 0
suez canal university ethics commetti
Ethics committee address [1] 288555 0
Suez CanalUniversity Ethics commetti
Suez Canal University
4 km street
Postcode 4356
Ismailia
Ethics committee country [1] 288555 0
Egypt
Date submitted for ethics approval [1] 288555 0
05/10/2011
Approval date [1] 288555 0
09/11/2011
Ethics approval number [1] 288555 0
5643

Summary
Brief summary

Abstract
Purpose:
To evaluate the use of red free light in the measurement of intraocular pressure using a Goldmann applanation tonometer without Fluorescein.

Materials and Methods:
Five hundred eyes of 250 patients attending the Ophthalmology Outpatient, Suez Canal University Clinic were measured for intraocular pressure using the same Goldmann applanation tonometer mounted on Haag-Streit Slit Lamp, measurement first were done with red free light without Fluorescein then other measurements were done with cobalt blue light and topical Fluorescein on the same eyes .
Results:
The Mean IOP was 15.23+/- 6.3 (SD) mm Hg using the red free light without Fluorescein while the mean was 15.78 +/- 6. 7 (SD) mm Hg using cobalt blue light and after application of Fluorescein in the conjunctival sac. On paired t test analysis, this difference was not significant.
Conclusion:
Measurement of IOP with Goldmann appanation tonometer with red free light without the use of Fluorescein is easy, simple, save time and give an accurate IOP measurement compared to traditional measurement with cobalt blue light and topical Fluorescein.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36666 0
A/Prof ehab ghoneim
Address 36666 0
el tammeem street
borg el harameen
6th floor
Zip code 323
portfoad
portsaid
Country 36666 0
Egypt
Phone 36666 0
00201223639848
Fax 36666 0
0020663408822
Email 36666 0
[email protected]
Contact person for public queries
Name 36667 0
A/Prof ehab ghoneim
Address 36667 0
el tammeem street
borg el harameen
6th floor
Zip tcode 323
portfoad
portsaid
Country 36667 0
Egypt
Phone 36667 0
00201223639848
Fax 36667 0
0020663408822
Email 36667 0
[email protected]
Contact person for scientific queries
Name 36668 0
A/Prof ehab ghoneim
Address 36668 0
el tammeem street
borg el harameen
6th floor
Zip code 323
portfoad
portsaid
Country 36668 0
Egypt
Phone 36668 0
00201223639848
Fax 36668 0
0020663408822
Email 36668 0
[email protected]

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No Supporting Document Provided



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