Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371280

Enrollment

Registered

2006-09-04

Start date

2005-11-30

Completion date

2006-11-30

Last updated

2010-05-12

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

Conditions

Anophthalmos, Orbital Implants

Keywords

hydroxyapatite, peg, prosthetic motility, orbital implant

Brief summary

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.

Interventions

PROCEDUREorbital implant

Implantation of pegged versus unpegged hydroxyapatite orbital implants

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Changing movement in up gaze: 0.58 mm	—
Changing movement in down gaze: 0.83 mm	—
Changing movement in medial gaze: 0.75 mm	—
Changing movement in lateral gaze: 1.2 mm	—

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026