Corneal Scarring Fibrosis
Conditions
Keywords
Corneal scar, Corneal scarring, Corneal haze, Corneal opacity, Topical losartan
Brief summary
This is a prospective, randomized, double-blinded, controlled clinical trial designed to evaluate the efficacy and safety of topical losartan in improving visual acuity, contrast sensitivity and reducing corneal densitometry, corneal aberrations and corneal scarring severity in adult patients with corneal scars of different etiologies. Participants will be randomly assigned to receive either topical losartan 0.8 mg/mL or placebo eyedrops 6 times per day for six months.
Detailed description
Corneal scarring is a significant cause of visual impairment worldwide, with limited conservative treatment options. Corticosteroids are commonly used but are associated with important adverse effects. Losartan, an angiotensin II receptor blocker, has demonstrated antifibrotic effects through inhibition of TGF-β signaling in experimental studies. This study aims to evaluate the safety and efficacy of topical losartan in improving visual function and corneal transparency in patients with corneal scarring fibrosis. Outcomes include changes in best-corrected visual acuity measured using the ETDRS chart, contrast sensitivity with FACT chart, corneal scar area calculated with ImageJ, corneal density assessed by Scheimpflug corneal densitometry, corneal aberrations using Zernike Analysis and clinical corneal scar severity evaluated using slit-lamp biomicroscopy with Fantes haze grading, compared with placebo. A total of 46 adult patients with stable corneal scars will be enrolled and followed for six months.
Interventions
DRUGTopical losartan
Drug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
DRUGPlacebo Control
Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Adults aged 18 years or older * Presence of corneal scar with a duration of at least 1 month * Corneal scars of any etiology * Corneal scars with or without corneal neovascularization * Stable corneal scar without epithelial defect * No active treatment for the underlying condition for at least 1 month *
Exclusion criteria
* Refusal or inability to provide written informed consent * Presence of corneal epithelial defect or friable epithelium * Age under 18 years * Pregnancy * Known allergy or hypersensitivity to losartan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | Baseline to 6 months. | BCVA measured using ETDRS chart and reported in LogMAR units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence | Baseline to 6 months. | Treatment adherence will be assessed based on daily patient adherence report. |
| Change in Contrast Sensitivity | Baseline to 6 months. | Contrast sensitivity will be evaluated using FACT chart. |
| Change in Corneal Haze Severity | Baseline to 6 months. | Corneal haze will be assessed using the Fantes Corneal Haze Grading Scale, evaluated by slit-lamp biomicroscopy. The scale ranges from 0 to 4. Grade 0: Clear with no opacity seen by any method of microscopic slit-lamp examination. Grade 0.5: Trace or faint haze seen only by indirect, broad tangential illumination. Grade 1: Haze of minimal density seen with difficulty with direct or diffuse examination. Grade 2: Mild haze easily visible with direct focal slit-lamp illumination. Grade 3: Moderate opacity that partially obscures details of the iris. Grade 4: Severe opacity that completely obscures the details of intraocular structures. The minimum possible score is 0 and the maximum possible score is 4. Higher scores indicate greater corneal opacity and worse clinical outcome. |
| Change in Corneal Scar Density | Baseline to 6 months | Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal densitometry and reported in grayscale units (GSU). |
| Change in Corneal Scar Area | Baseline to 6 months. | The area of corneal scarring will be measured using slit-lamp corneal photography and analyzed with Image J software, reported in square millimeters (mm²). |
| Change in corneal aberrations | Baseline to 6 months. | Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal Zernike Analysis reported micron. |
| Change in Intraocular Pressure | Baseline to 6 months. | Intraocular pressure will be measured using Goldmann applanation tonometry to monitor ocular safety. |
| Change in corneal pachymetry | Baseline to 6 months. | Corneal pachymetry will be measeured using optical coherence tomography. |
| Treatment Adverse Events | Baseline to 6 months. | Treatment adverse events will be assessed based on patient-reported ocular discomfort and recorded adverse events during follow-up visits. |
| Corneal scar depth | Baseline to 6 months. | Corneal scar depth will be evaluated using optical coherence tomography line scan. |
Countries
Mexico
Contacts
CONTACTKarim Mohamed-Noriega, Dr. med.
PRINCIPAL_INVESTIGATORKarim Mohamed-Noriega, Dr. med.
Universidad Autonoma de Nuevo Leon
Outcome results
None listed