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IRCT2017021132503N1 IRCT 2017-06-26 investigator Safety and efficacy of fibrin glue prepared from umbilical cord blood in pterygium excision Safety and efficacy of fibrin glue prepared from umbilical cord blood for attaching Conjunctival graft after pterygium excision 2017-03-28 anticipated 30 Complete https://irct.ir/trial/25311 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be attained by using of random number tables. 1 Pterygium. Intervention 1: Intervention group: The UCB-fibrin glue will be formulated in Royan Institute, Tehran, Iran. This is a prepared drop from the umbilical cord blood plasma of healthy mothers under sterile condition. In operation room, two drops of UCB-thrombin and one drop of UCB-Fibrinogen will be mixed and the resulting mixture will be put beyond the graft on its posterior position in a way that its limbus will be directed towards the limbus of the lesion. Intervention 2: Control group: In control group, by using standard fibrin glue (Beriplast P, Germany), under company protocol, two drops of thrombin and one drop of fibrinogen will be used under the posterior surface of the graft in a way that its limbus will be directed towards the limbus of the lesion.
public Marzieh Ebrahimi
Royan Institute for Stem Cell Biology and Technology, , Hafez street, Hemmat highway
Tehran Iran (Islamic Republic of) +98 989123448359 marzieh.ebrahimi@gmail.com Royan Institute for Stem Cell Biology and Technology scientific Khosrow Jadidi
Department of Ophthalmology, Baqiyatallah university of Medical Sciences, Molasadra street
tehran Iran (Islamic Republic of) +98 21 8248 2260 Kh.jadidi@gmail.com Baqiyatallah university of Medical Sciences Iran (Islamic Republic of) 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. 20 years 75 years Both H11.0 Conjunctival degenerations and deposits Treatment - Surgery Treatment - Surgery Intervention group: The UCB-fibrin glue will be formulated in Royan Institute, Tehran, Iran. This is a prepared drop from the umbilical cord blood plasma of healthy mothers under sterile condition. In operation room, two drops of UCB-thrombin and one drop of UCB-Fibrinogen will be mixed and the resulting mixture will be put beyond the graft on its posterior position in a way that its limbus will be directed towards the limbus of the lesion Control group: In control group, by using standard fibrin glue (Beriplast P, Germany), under company protocol, two drops of thrombin and one drop of fibrinogen will be used under the posterior surface of the graft in a way that its limbus will be directed towards the limbus of the lesion. 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. None None investigator Approved 2014-08-20 Baqiyatallah University of Medical sciences Baqiyatallah University of Medical sciences Tehran Iran (Islamic Republic of)