Phase
Condition
Eye Disorders/infections
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged between 18 and 80 years old;
Epithelial ulceration in a dendritic or geographic pattern, characteristic ofinfection with herpes simplex virus, and within 7 days of onset;
Ulcer's stromal involvement < 120 micron, as indicated by anterior segment opticalcoherence tomography;
Informed consent signed by patient or legal guardian. Having the ability to complywith study assessments for the full duration of the study.
Exclusion
Exclusion Criteria:
Clinical signs of a cause other than herpes simplex virus for the epithelialkeratitis;
Antivirus or corticosteroid treatment within 6 months;
Active stromal keratitis or iritis;
History of allergy or adverse reaction to ganciclovir;
High myopia with a spherical equivalent of -15.0 D or less;
Corneal or ocular surface infection within 30 days prior to study entry;
Ocular surface malignancy;
Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
Renal failure with creatinine clearance< 25ml/min;
Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
Platelet levels < 150,000 or > 450,000 per microliter;
Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
Prothrombin time > 16s and activated partial thrombin time > 35s in patients notaccepting anticoagulant therapy; An international normalized ratio greater than 3 inpatients accepting anticoagulant therapy;
Pregnancy (positive test) or lactation;
Participation in another simultaneous medical investigation or clinical trial;
Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
Any medical or social condition that in the judgement of the investigator wouldinterfere with or serve as a contraindication to adherence to the study protocol orability to give informed consent;
Active immunological diseases;
History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucomafiltering surgeries.
Study Design
Connect with a study center
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong 5
ChinaActive - Recruiting
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