Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Orbital Implants; Anophthalmos

Treatments: Procedure: orbital implant

Study type: Interventional

Funder types: Other

Identifiers

NCT00371280

8422

Details and patient eligibility

About

Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• orbital hydroxyapatite implants

Exclusion criteria

• history of systemic disease
• history of radio therapy
• secondary hydroxapatite implant
• complications lead to re-surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Pegged unpegged hydroxyapatite orbital implantation

Treatment:

Procedure: orbital implant

2

Active Comparator group

Description:

Unpegged hydroxyapatite orbital implantation

Treatment:

Procedure: orbital implant