- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549815
Measuring the Changes of the Intraocular Pressure After Corneal Laser Refractive Surgery Using Different Techniques
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be prospective study. 50 Patients who will undergo refractive surgery referred from the out-patient clinic of Tanta University hospital between December 2025 and December 2026 will be included in the study . The patient will be randomly selected to do either LASIK, PRK or femtosecond laser LASIK
Patients who will undergo refractive surgery either PRK, LASIK or femtosecond laser with age between 19 and 35 years old , Myopia range from (-2.00 to -6.00 Diopter) and to maintain stability of the data we will use only the right eye of each patient will be included on the study
Kertoconus, Corneal scarring, Previous corneal infections, Minimum corneal thickness at the thinnest location less than 400 µm, History of uveitis or ocular allergy and Pre-existing glaucoma will be excluded from the study.
Age, sex, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest and cycloplegic refraction, Slit lamp biomicroscopy, fundus examination , Central corneal thickness (CCT) and average Keratometer (K) data will be collected
Intraocular pressure will be measured by by two methods : Corvis CT and applanation tonometer for each patient and will be recorded, all the data will be collected before the refractive surgery and one month after refractive surgery
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dina Tadros, Ass Professor of Ophthalmology
- Phone Number: +201224093354
- Email: dina.tadros@med.tanta.edu.eg
Study Locations
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Tanta, Egypt, 31515
- Tanta Univeristy Hospital
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Contact:
- Tamer Ibrahim, Ass professor
- Phone Number: +201001243049
- Email: dinasabry71@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 19 and 35 years old
- Myopia range from (-2.00 to -6.00 Diopter) .
Exclusion Criteria:
- Kertoconus.
- Corneal scarring.
- Previous corneal infections.
- Minimum corneal thickness at the thinnest location less than 400 µm.
- History of uveitis or ocular allergy.
- Pre-existing glaucoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Measuring intraocular pressure by using different techniques
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Measuring intraocular pressure by different methods and compare the results
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring intraocular pressure
Time Frame: -The data collected will be before that laser surgery and one month after surgery
|
Intraocular pressure will be measured by in mmHg and by two methods : Corvis CT and applanation tonometer for each patient and will be recorded
|
-The data collected will be before that laser surgery and one month after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1. Bailey MD, Zadnik K (2007) Outcomes of LASIK for myopia with FDA-approved lasers. Cornea 26(3):246-254 2. Sridhar MS, Rao SK, Vajpayee RB, Aasuri MK, Hannush S, Sinha R (2002) Complications of laser-in situ-ker- atomileusis. Indian J Ophthalmol 50(4):265-282 3. Mohammadi SF, Nabovati P, Mirzajani A, Ashrafi E, Vakilian B (2015) Risk factors of regression and under- correction in photorefractive keratectomy: a case-control study. Int J Ophthalmol 18;8(5): 933-937 4. Diakonis VF, Kankariya VP, Kymionis GD, Kounis G, Kontadakis G, Gkenos E, Grentzelos MA, Hajithanasis G, Yoo SH, Pallikaris IG (2014) Long term followup of pho- torefractive keratectomy with adjuvant use of mitomycin C. J Ophthalmol 2014:821920 5- dos Santos AM, Torricelli AA, Marino GK, Garcia R, Netto MV, Bechara SJ, Wilson SE. Femtosecond Laser-Assisted LASIK Flap Complications. J Refract Surg. 2016 Jan;32(1):52-9 6- Wang LK, Tian L and Zheng YP. Determining in vivo elasticity and viscosity with dynamic Scheimpflug imaging analysis in keratoconic and healthy eyes. J Biophotonics, 2016; 9: 454-463. 7.ConsejoA,MelcerT,RozemaJJ.Introductiontomachinelearningforophthalmologists.SeminOphthalmol.2019;34(1):19 _41.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 36264PR1310100/12/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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