Clinical trial NCT06243991: The Effect Of High And Low Molecular Weight Sodium Hyaluronic Acid Eye Drops After Crosslinking
Official title: The Effect Of High And Low Molecular Weight Sodium Hyaluronic Acid Eye Drops On Corneal Recovery After Crosslinking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Corneal crosslinking, corneal nerve regeneration, in-vivo corneal confocal microscopy, sodium hyaluronic acid,
high molecular weight hyaluronic acid
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty-five patients with keratoconus were included in the study. All participants underwent accelerated epithelium-off CXL (A-CXL) for 10 minutes with 9 mW/cm² ultraviolet-A irradiation. A total of 63 eyes from 55 keratoconus patients were assigned into three groups: 17 patiens (20 eyes) in the HMW-HA group, 22 patient (23 eyes) in the LMW-HA group, and 20 patient (20 eyes) in the control group.

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 (n:23) 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 (www.random.org/integers) 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®, i.com 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 mW/cm² ultraviolet-A irradiation. The postoperative standard treatment regimen included topical moxifloxacin (0.5% Vigamox, Alcon Inc, USA) for one week, topical dexamethasone (0.1% Dexasine-SE, Kaysersberg Pharmaceuticals, France) for one week after epithelial closure, followed by topical loteprednol 0.5% (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.

Eligibility criteria: Inclusion Criteria:

* Keratoconus patiens aged 18 and above who had been scheduled for corneal crosslinking

Exclusion Criteria:

* Dry eye disease, corneal thickness below 400 micrometer, pregnancy, breastfeeding, topical or systemic drug use, eye disease other than keratoconus, systemic diseases, active atopy or allergy, contact lens use, ocular surgery history.

Primary outcomes:
measure: Corneal nerve fiber density (CNFD)
timeFrame: Baseline
measure: Corneal nerve fiber density (CNFD)
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Corneal nerve branch density (CNBD)
timeFrame: Baseline
measure: Corneal nerve branch density (CNBD)
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Corneal nerve fiber length (CNFL)
timeFrame: Baseline
measure: Corneal nerve fiber length (CNFL)
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Corneal nerve fiber total branching density (CTBD)
timeFrame: Baseline
measure: Corneal nerve fiber total branching density (CTBD)
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Corneal Sensitivity
timeFrame: Baseline
measure: Corneal Sensitivity
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Dendritic cell density
timeFrame: Baseline
measure: Dendritic cell density
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Ocular surface disease Index (OSDI) questionnaire
timeFrame: Baseline
measure: Ocular surface disease Index (OSDI) questionnaire
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
measure: Non invaziv tear break-up time (NI-TBUT)
timeFrame: Baseline
measure: Non invaziv tear break-up time (NI-TBUT)
timeFrame: Postoperative 1st, 3rd, 6th and 12th months
Secondary outcomes:
measure: Visual Functions
timeFrame: Baseline
measure: Refractive Outcomes
timeFrame: Postoperative 1st, 3rd and 6th months
measure: Keratometric Findings
timeFrame: Baseline
measure: Keratometric Findings
timeFrame: Postoperative 1st, 3rd and 6th months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Pendik
Study officials:
affiliation: Marmara University
name: Semra Akkaya Turhan, Assoc. prof.
role: STUDY_CHAIR
References: