NCT00371280

UnknownPhase 2/3

Prosthetic Motility and Complications in Pegged Versus Unpeg...

Shahid Beheshti University of Medical Sciences Source

Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

8422

Study Type

interventional

Estimated enrollment

50

Locations

1 country

Sites

1

Timeline

Study Start

November 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2006

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2006

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 50 participants
Study completion date: November 2006
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 1, 2006
Actual (reported)
First Posted
September 4, 2006
Actual (reported)
Primary Completion
October 2006
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2006
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 12, 2010
Status Verified: June 2008
Last Update Submitted: May 10, 2010

Conditions

Anophthalmos Orbital 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Shahid Beheshti University of Medical Sciences
Otherlead

Study Sites (1)

Babak Babsharif, MD

Tehran, Tehran Province, 16666, Iran

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 3
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 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2006

Estimated (date passed)

history of systemic disease

history of radio therapy

secondary hydroxapatite implant

complications lead to re-surgery

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2006

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 12, 2010

Record last verified: 2008-06

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00371280
Data provider: ClinicalTrials.gov
Source updated: 2010-05-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:15 UTC

Locations

IR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations