Safety and Efficacy of Acellular Dermal Graft in Orbital Fracture Repair

Safety and Efficacy of Acellular Dermal Graft (ADG) in Orbital Fracture Repair; A Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220424054640N3

Enrollment

Registered

2022-09-16

Start date

2022-09-22

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Condition 1: Inferior wall fracture of orbit. Condition 2: medial wall fracture of orbit. fracture of orbital floor Fracture of medial orbital wall

Interventions

Intervention group: All patients will undergo examination and recording of visual acuity, eye movements and exophthalmometery before surgery. CT-scan is performed for all patients before surgery. pati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Fracture of the orbital floor or medial wall with one of the following characteristics: Fractures more than 50% of the orbital floor Muscle entrapment Enophthalmus that affecting cosmetic issues Hypoglobus that affecting cosmetic issues

Exclusion criteria

Exclusion criteria: Patients who previously underwent orbital surgery.

Design outcomes

Primary

Measure	Time frame
The amount of correction of eye motility. Timepoint: One month, three months and six months after surgery. Method of measurement: examination.;The amount of correction of hypoglobus. Timepoint: One month, three months and six months after surgery. Method of measurement: Neugle exophthalmometer.;The amount of correction of enophthalmus. Timepoint: One month, three months and six months after surgery. Method of measurement: Hertel exophthalmometer.;Prevalence of reactive symptoms to alloplastic material. Timepoint: One month, three months and six months after surgery. Method of measurement: History and examination.;The degree of orbit inflammation and infection. Timepoint: One month, three months and six months after surgery. Method of measurement: History and examination.;The amount of implant protrusion. Timepoint: One month, three months and six months after surgery. Method of measurement: Examination and CT scan.;The rate of visual function loss: visual acuity. Timepoint: One month, three months and six months after surgery. Method of measurement: snallen chart.;The rate of visual function loss: Marcus Gunn's pupil. Timepoint: One month, three months and six months after surgery. Method of measurement: examination with muscle light.;The rate of visual function loss: visual field. Timepoint: One month, three months and six months after surgery. Method of measurement: Humphrey visual field: 24-2 SITA standard.	—

Measure

Time frame

The amount of correction of eye motility. Timepoint: One month, three months and six months after surgery. Method of measurement: examination.;The amount of correction of hypoglobus. Timepoint: One month, three months and six months after surgery. Method of measurement: Neugle exophthalmometer.;The amount of correction of enophthalmus. Timepoint: One month, three months and six months after surgery. Method of measurement: Hertel exophthalmometer.;Prevalence of reactive symptoms to alloplastic material. Timepoint: One month, three months and six months after surgery. Method of measurement: History and examination.;The degree of orbit inflammation and infection. Timepoint: One month, three months and six months after surgery. Method of measurement: History and examination.;The amount of implant protrusion. Timepoint: One month, three months and six months after surgery. Method of measurement: Examination and CT scan.;The rate of visual function loss: visual acuity. Timepoint: One month, three months and six months after surgery. Method of measurement: snallen chart.;The rate of visual function loss: Marcus Gunn's pupil. Timepoint: One month, three months and six months after surgery. Method of measurement: examination with muscle light.;The rate of visual function loss: visual field. Timepoint: One month, three months and six months after surgery. Method of measurement: Humphrey visual field: 24-2 SITA standard.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasser Karimi

Iran University of Medical Sciences

drnasserkarimi@gmail.com+98 912 327 2376

Outcome results

None listed

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