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Trial · NCT05528172

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Central Corneal Endothelial Cell Density (ECD) at Week 12Baseline to Week 12Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
SecondaryChange From Baseline in Central Corneal ECD at Each VisitBaseline to Week 26Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
SecondaryChange From Baseline in Peripheral Corneal ECD (Nasal)Baseline to Week 26Peripheral corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
SecondaryChange From Baseline in Peripheral Corneal ECD (Temporal)Baseline to Week 26Corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
SecondaryChange From Baseline in Central Corneal ThicknessBaseline to Week 26Corneal thickness measured by contact ultrasound pachymetry or optical pachymetry recorded in micrometers (μm)
SecondaryNumber of Subjects With No Evidence of Corneal EdemaBaseline to Week 26Corneal edema of the study eye, evaluated by slit-lamp examination, recorded as present or absent, and categorized by anatomical location.
SecondaryChange From Baseline in Best-Corrected Visual Acuity (BCVA)Baseline to Week 26Best-corrected visual acuity (BCVA) of the study eye, assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
SecondaryChange From Baseline in VFQ-25 (Overall)Baseline to Week 26
Visual Function assessed using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), a patient-reported measure of vision-related functioning and quality of life. Scores range from 0 to 100, with higher scores indicating better visual function and lower scores indicating worse visual function. The total composite score is derived from multiple subscales using the standard VFQ-25 scoring method.
SecondaryShifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)Baseline to Week 26
Shift in slit-lamp biomicroscopy findings of the study eye categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. \- Baseline to Post-Baseline Shift
SecondaryShifts in Slit-lamp Biomicroscopy (Cornea)Baseline to Week 26
Shift in slit-lamp biomicroscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift
SecondaryShifts in Dilated Fundoscopy (Central Retina)Baseline to Week 26
Shift in dilated fundoscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift
SecondaryChange From Baseline in Intraocular Pressure (mmHg)Baseline to Week 26Intraocular pressure (IOP) of the study eye, measured using either a contact or non-contact tonometer, and recorded in millimeters of mercury (mm Hg).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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