NCT00371280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 12, 2010

Status Verified

June 1, 2008

Enrollment Period

11 months

First QC Date

September 1, 2006

Last Update Submit

May 10, 2010

Conditions

AnophthalmosOrbital Implants

Keywords

hydroxyapatitepegprosthetic motilityorbital implant

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Pegged unpegged hydroxyapatite orbital implantation

Procedure: orbital implant

2

ACTIVE COMPARATOR

Unpegged hydroxyapatite orbital implantation

Procedure: orbital implant

Interventions

orbital implantPROCEDURE

Implantation of pegged versus unpegged hydroxyapatite orbital implants

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • orbital hydroxyapatite implants

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babak Babsharif, MD

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Anophthalmos

Interventions

Orbital Implants

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Babak Babsharif, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

November 1, 2005

Primary Completion

October 1, 2006

Study Completion

November 1, 2006

Last Updated

May 12, 2010

Record last verified: 2008-06

Locations

IR(1)