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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017021132503N1

Enrollment

Registered

2017-06-26

Start date

2017-03-28

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium. Conjunctival degenerations and deposits

Interventions

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 s

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 conditio

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 surfac

Eligibility

Sex/Gender

All

Age

20 Years to 75 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Ebrahimi

Royan Institute for Stem Cell Biology and Technology

marzieh.ebrahimi@gmail.com+98 989123448359

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026