Safety and efficacy of fibrin glue prepared from umbilical cord blood in pterygium excisio
Phase 1
- Conditions
- Pterygium.Conjunctival degenerations and deposits
- Registration Number
- IRCT2017021132503N1
- Lead Sponsor
- investigator
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients who are suffering from pterygium associated with reduced visual acuity due to the proximity of pterygium to the visual axis, irregular astigmatism, and considerable ocular discomforts which are not responsive to the standard cares will be included in this study, whereas those who are suspected to ocular surface malignancies and/or keratoconjunctivitis, recurrent pterygium, and other general diseases (eg. Diabetes, hypertension) will be excluded.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subconjunctival hemorrhage. Timepoint: 1,3 and 5 day and 1 and 3 months after surgery. Method of measurement: Mild:less than 1/3of graft, Moderate: from 1/3 to 2/3 of graft and sever: more than 2/3 of graft.;Hyperemia. Timepoint: 1,3 and 5 day and 1 and 3 months after surgery. Method of measurement: Grade 0 – Absent (in case of normal vessels), Grade I – Mild (low vascular hyperemia), Grade II – Moderate (disseminated hyperemia), and Grade III – severe (hyperemia with disseminated vascular dilatation.;Complete loss of graft. Timepoint: 1,3 and 5 day and 1 and 3 months after surgery. Method of measurement: observation.;Partial graft dehiscence. Timepoint: 1,3 and 5 day and 1 and 3 months after surgery. Method of measurement: observation.;Recurrence rate. Timepoint: 1 and 3 month after surgery. Method of measurement: observation.
- Secondary Outcome Measures
Name Time Method