Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243991
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Brief Title:
The Effect Of High And Low Molecular Weight Sodium Hyaluronic Acid Eye Drops After Crosslinking
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect Of High And Low Molecular Weight Sodium Hyaluronic Acid Eye Drops On Corneal Recovery After Crosslinking
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose The objective of this investigation was to assess the impact of eye drops containing high molecular weight hyaluronic acid HMW-HA and low molecular weight hyaluronic acid LMW-HA on corneal nerve regeneration dendritic cell DC density corneal sensitivity CS and ocular surface parameters in patients with keratoconus following corneal crosslinking CXL
Methods Sixty-three eyes of 55 keratoconus patients were randomized to instill eye drops containing HMW-HA n 20 for 12 months LMW-HA n23 for 12 months and polyvinyl alcohol n 20 until the epithelial defect closure in the control group after CXL Subbasal nerve plexsus SNP was imaged with corneal confocal microscopy CCM and ACCMetrics program was used to quantify corneal nerve fiber density CNFD corneal nerve fiber length CNFL corneal nerve fiber branching density CNBD and corneal nerve fiber total branching density CTBD DC density was calculated with Image J software CS was measured using the Cochet-Bonnet esthesiometer Ocular Surface Disease Index OSDI questionnaire non-invasive break-up time NI-TBUT were evaluated All measurements were performed before CXL and postoperatively after 1 3 6 and 12 months
Methods Sixty-three eyes of 55 keratoconus patients were randomized to instill eye drops containing HMW-HA n 20 for 12 months LMW-HA n23 for 12 months and polyvinyl alcohol n 20 until the epithelial defect closure in the control group after CXL Subbasal nerve plexsus SNP was imaged with corneal confocal microscopy CCM and ACCMetrics program was used to quantify corneal nerve fiber density CNFD corneal nerve fiber length CNFL corneal nerve fiber branching density CNBD and corneal nerve fiber total branching density CTBD DC density was calculated with Image J software CS was measured using the Cochet-Bonnet esthesiometer Ocular Surface Disease Index OSDI questionnaire non-invasive break-up time NI-TBUT were evaluated All measurements were performed before CXL and postoperatively after 1 3 6 and 12 months
Detailed Description:
This study assessed individuals aged 18 and above diagnosed with keratoconus and scheduled for epithelium-off CXL A total of 63 eyes from 55 keratoconus patients were randomly assigned using computer-generated randomization wwwrandomorgintegers into three groups 20 eyes in the HMW-HA group 23 eyes in the LMW-HA group and 20 eyes in the control group without the administration of artificial tears
Post-CXL the HMW-HA group received topical HMW-HA Comfort Shield icom medical GmbH Munich Germany three times daily for 12 months the LMW-HA group received topical LMW-HA Thealose Duo Thea Clermont-Ferrand France three times daily for 12 months and the control group received topical polyvinyl alcohol Refresh Allergan Dublin Ireland three times daily until epithelial defect closure All participants underwent accelerated epithelium-off CXL A-CXL for 10 minutes with 9 mWcm² ultraviolet-A irradiation The postoperative standard treatment regimen included topical moxifloxacin 05 Vigamox Alcon Inc USA for one week topical dexamethasone 01 Dexasine-SE Kaysersberg Pharmaceuticals France for one week after epithelial closure followed by topical loteprednol 05 Lotemax Bausch Lomb USA for three weeks
Uncorrected visual acuity UCVA best-corrected visual acuity BCVA and manifest spherical equivalent SE were recorded at all visits The assessment was carried out in the following order Ocular Surface Disease Index OSDI questionnaire noninvasive tear break-up time NIBUT corneal tomography Pentacam OCULUS Wetzlar Germany corneal sensitivity corneal fluorescein staining and CCM imaging Examinations were conducted preoperatively and at the postoperative 1th 3rd 6th and 12th months
Post-CXL the HMW-HA group received topical HMW-HA Comfort Shield icom medical GmbH Munich Germany three times daily for 12 months the LMW-HA group received topical LMW-HA Thealose Duo Thea Clermont-Ferrand France three times daily for 12 months and the control group received topical polyvinyl alcohol Refresh Allergan Dublin Ireland three times daily until epithelial defect closure All participants underwent accelerated epithelium-off CXL A-CXL for 10 minutes with 9 mWcm² ultraviolet-A irradiation The postoperative standard treatment regimen included topical moxifloxacin 05 Vigamox Alcon Inc USA for one week topical dexamethasone 01 Dexasine-SE Kaysersberg Pharmaceuticals France for one week after epithelial closure followed by topical loteprednol 05 Lotemax Bausch Lomb USA for three weeks
Uncorrected visual acuity UCVA best-corrected visual acuity BCVA and manifest spherical equivalent SE were recorded at all visits The assessment was carried out in the following order Ocular Surface Disease Index OSDI questionnaire noninvasive tear break-up time NIBUT corneal tomography Pentacam OCULUS Wetzlar Germany corneal sensitivity corneal fluorescein staining and CCM imaging Examinations were conducted preoperatively and at the postoperative 1th 3rd 6th and 12th months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None