Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540131
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Studying the Effect of Ethanol Applied on the Corneal Surface During PRK Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Ethyle Alcohol Contact Time on Corneal Epithelial Healing in Cases of Photorefractive Keratectomy
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the effects of the duration of ethanol contact with the corneal surface The main question it aims to answer is Does this affect the behavior of corneal epithelial healing
Detailed Description:
The study was carried out on 70 patients who were candidates for laser corneal refractive surgery with alcohol-assisted PRK The study comprised two groups Group 1 included the right eye of the patients and Group 2 included the left eye of the same patients Group 1 was operated with PRK with alcohol 20 applied for 15 seconds while group 2 underwent PRK with alcohol 20 applied for 30 seconds Mitomycin C MMC 002 was applied for 30 seconds after the laser ablation in both groups
Inclusions criteria
The included patients should meet the following criteria age between 18 and 35 years both genders with normal corneal topography clear cornea and stable refractive error for at least 12 months before the surgery Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error cylindrical error of more than -15D and an estimated stromal ablation depth of less than 70 µm
Exclusion criteria
The patients were excluded from the study if they had one or more of the following findings patients with mixed astigmatism in either eye contact lens wearers abnormal corneal topography thin cornea less than 500 microns corneal opacity dry eye disease history of herpetic keratitis corneal epithelial pathology dystrophies or scarring atopy collagen diseases autoimmune disease systemic diseases that interfere with healing eg diabetes mellitus eyelid diseases ocular pathology previous history of refractive or corneal surgery and pregnant or lactating females Also patients who failed to attend the follow-up visits were excluded
Preoperative assessment The following preoperative measurements and examinations were performed Uncorrected visual acuity UCVA and best-corrected visual acuity BCVA using Snellens charts Manifest and cycloplegic refractions were measured with the autorefractorkeratometer Intraocular pressure measurement was done using the I Care Tonometer Clinical examination with the slit-lamp biomicroscopy including dilated fundus examination of the posterior segment Then patients were examined with Pentacam HR Oculus Optikger- ate GmbH Wetzlar Germany for corneal assessment and with I design for higher order aberration measurement
Operative details
Preoperatively antibiotic Moxifloxacin hydrochloride 05 and anesthetic benoxinate hydrochloride 04 eye drops were instilled on the corneal surface Povidone-iodine 5 solution was used for sterilization and an eyelid closed loop speculum was used to keep the eyes wide open during the procedure
Epithelial removal was done with a sponge soaked in a 20 ethanol solution applied on the central corneal surface for 15 seconds in the right eye group 1 and for 30 seconds in the left eye group 2 of the same patient Then the corneal surface was flushed with a balanced salt solution BSS to remove alcohol remnants This was followed by epithelial delamination with a dry cellulose sponge to debride an 8 mm area A blunt spatula was used to complete this step if epithelial removal was difficult with the sponge
Subsequently customized PRK was performed on the dry Bowmans layer surface by VISX star S4 excimer laser Abbott Medical Optics Inc AMO Santa Ana CA USA The targeted postoperative refraction was emmetropia for all patients
The patients were treated with topical instillation of antibiotic drops gatifloxacin 05 four times daily for one week topical instillation of steroid drops prednisolone 1 four times daily for 2 weeks then 3 times for 2 weeks At the second month prednisolone was substituted by fluorometholone 01 drops for 2 weeksamp artificial tear drops sodium hyaluronate 02 five times daily for 3-months An adjuvant therapy was added to the standard treatment regimen to augment the epithelial healing process vitamin C 500 mg capsules twice per day amp vitamin A 50000 IU capsules once per day both for 2 weeks
All patients were examined daily until complete epithelial healing then after 1 week and 3 weeks Contact lenses were removed for all patients after 7 days
Pain assessment
The patients recorded their pain using a validated numerical rating scale NRS where the patients subjectively rated their pain on an eleven-point numerical scale from 0 no pain to 10 worst imaginable pain16
Inclusions criteria
The included patients should meet the following criteria age between 18 and 35 years both genders with normal corneal topography clear cornea and stable refractive error for at least 12 months before the surgery Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error cylindrical error of more than -15D and an estimated stromal ablation depth of less than 70 µm
Exclusion criteria
The patients were excluded from the study if they had one or more of the following findings patients with mixed astigmatism in either eye contact lens wearers abnormal corneal topography thin cornea less than 500 microns corneal opacity dry eye disease history of herpetic keratitis corneal epithelial pathology dystrophies or scarring atopy collagen diseases autoimmune disease systemic diseases that interfere with healing eg diabetes mellitus eyelid diseases ocular pathology previous history of refractive or corneal surgery and pregnant or lactating females Also patients who failed to attend the follow-up visits were excluded
Preoperative assessment The following preoperative measurements and examinations were performed Uncorrected visual acuity UCVA and best-corrected visual acuity BCVA using Snellens charts Manifest and cycloplegic refractions were measured with the autorefractorkeratometer Intraocular pressure measurement was done using the I Care Tonometer Clinical examination with the slit-lamp biomicroscopy including dilated fundus examination of the posterior segment Then patients were examined with Pentacam HR Oculus Optikger- ate GmbH Wetzlar Germany for corneal assessment and with I design for higher order aberration measurement
Operative details
Preoperatively antibiotic Moxifloxacin hydrochloride 05 and anesthetic benoxinate hydrochloride 04 eye drops were instilled on the corneal surface Povidone-iodine 5 solution was used for sterilization and an eyelid closed loop speculum was used to keep the eyes wide open during the procedure
Epithelial removal was done with a sponge soaked in a 20 ethanol solution applied on the central corneal surface for 15 seconds in the right eye group 1 and for 30 seconds in the left eye group 2 of the same patient Then the corneal surface was flushed with a balanced salt solution BSS to remove alcohol remnants This was followed by epithelial delamination with a dry cellulose sponge to debride an 8 mm area A blunt spatula was used to complete this step if epithelial removal was difficult with the sponge
Subsequently customized PRK was performed on the dry Bowmans layer surface by VISX star S4 excimer laser Abbott Medical Optics Inc AMO Santa Ana CA USA The targeted postoperative refraction was emmetropia for all patients
The patients were treated with topical instillation of antibiotic drops gatifloxacin 05 four times daily for one week topical instillation of steroid drops prednisolone 1 four times daily for 2 weeks then 3 times for 2 weeks At the second month prednisolone was substituted by fluorometholone 01 drops for 2 weeksamp artificial tear drops sodium hyaluronate 02 five times daily for 3-months An adjuvant therapy was added to the standard treatment regimen to augment the epithelial healing process vitamin C 500 mg capsules twice per day amp vitamin A 50000 IU capsules once per day both for 2 weeks
All patients were examined daily until complete epithelial healing then after 1 week and 3 weeks Contact lenses were removed for all patients after 7 days
Pain assessment
The patients recorded their pain using a validated numerical rating scale NRS where the patients subjectively rated their pain on an eleven-point numerical scale from 0 no pain to 10 worst imaginable pain16
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None