Orbital DeformityOrbitalProsthNCT07078162
Accuracy of Fitting Surface of Orbital Prosthesis Constructed by Photogrammetry Scan
A study testing Photogramety Orbital Prosthesis and Conventional impression prosthesis in people with Orbital Deformity, run by Tanta University at 1 site in Egypt.
Trial summary
Two orbital prosthesis were made to the patient , using two different digital scanning methods to restore the unilateral orbital exentration , the prosthetic devices were made using medical silicon material Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Orbital Deformity
- What is being tested?
- Photogramety Orbital Prosthesis and Conventional impression prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2024to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Unilateral orbital defect.
- Complete healing of the defect site with no open wound.
- At least 1 year passed after the last chemo or radiotherapy dose in patients who receiving this type of treatment
Who cannot join
- Patient under chemo or radiotherapy due to presence of active tumor.
- Patient with unhealed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Of Fitting Surface Of Orbital Prosthesis Constructed By Photogrammetry Scan
Two orbital prosthesis were made to the patient , using two different digital scanning methods to restore the unilateral orbital exentration , the prosthetic devices were made using medical silicon material
Read the detailed description
Statement of problem : Orbital defects which resulted from surgical removal of mucormycosis that caused by corona virus infection lead to several functional, esthetic and psychological problems for the patients.
Aim of the study : Evaluation of the accuracy of fitting surface of orbital prosthesis constructed by photogrammetry scan.
Methods : An orbital prosthesis was made using photogrammetry scanning technique as a method for making digital facial impression to obtain facial 3D model using a high resolution professional camera with image processed through 3DF Zephyr open-source software and the other orbital prosthesis was made using a conventional impression for both the defect and contralateral healthy eye , then scanned with a Degree Of Freedom (DOF) extra oral desktop scanner. 3D models of the defect sites were printed from each scanning method to act as a master cast for the orbital prosthesis fabrication. Accuracy of orbital prosthesis fitting surfaces produced from the two techniques in comparison with a facial scan as a reference scan was assessed through deviation analysis using metrology grade software (Geomagic Control X ).
- Conditions
- Orbital Deformity
- Being tested
- Photogramety Orbital Prosthesis, Conventional impression prosthesis
- Keywords
- Orbital Prosthesis, Photogrammetry, Impression, 3D printing, Silicone, Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photogramety Orbital ProsthesisOther
Using 2D photographs to abtain 3D model of orbital defect anatomy
Conventional impression prosthesisOther
Conventional impression to an orbital defect then scaning the impression using desktop scanner
| Study group | Role | What they receive |
|---|---|---|
| 1- photogrammetry scan to the defect and healthy sites | Other | Capture photographs of the face including the defective site by profesional camera Receives: Other: Photogramety Orbital Prosthesis |
| 2- Digital scan of a conventional impression to the defect and healthy sites | Other | Digital scan of a conventional impression to the defect and healthy sites, the impression was taken using silicone rubber impression material, to obtain 3D virtual model using an extraoral desktop scanner. Receives: Other: Conventional impression prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of fitting surface of orbital prosthesis
Measurements of accuracy:
Measuring surfaces mesh deviation between the two orbital prosthesis fitting surfaces obtained using two types of scanning methods and a reference facial scan obtained using creality raptor (CR) scanner.
- The STL file of the facial scan and the STL files of the two orbital prosthesis fitting surfaces were imported separately to the metrology grade software program( Geomagic control x) .
- The STL file of the facial scan was selected and considered to be the reference data , and the STL files of the prosthesis fitting surfaces was selected and considered to be the measured data .
- The STL file of the measured data was manually superimposed onto the STL file of the reference data .
- A color surface map appeared on the reference data which indicate the directional mesh deviation result between the superimposed scans .
- The color map scale was adjusted .
Measured: Baseline or Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start23 Jun 2024
- Primary completion23 Apr 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital DeformityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abd Allah Hassan Hashish, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078162
- Sponsor's protocol ID
- Orbital prosthesis
- Other IDs
- 2950729
- Acronym
- OrbitalProsth
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for the patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Of Fitting Surface Of Orbital Prosthesis Constructed By Photogrammetry Scan
- ClinicalTrials.gov ID
- NCT07078162
- Acronym / sponsor ID
- OrbitalProsth / Orbital prosthesis
- Conditions
- Orbital Deformity
- Keywords
- Orbital Prosthesis, Photogrammetry, Impression, 3D printing, Silicone, Accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two orbital prosthesis were made to the patient , using two different digital scanning methods to restore the unilateral orbital exentration , the prosthetic devices were made using medical silicon material
Detailed description
Statement of problem : Orbital defects which resulted from surgical removal of mucormycosis that caused by corona virus infection lead to several functional, esthetic and psychological problems for the patients.
Aim of the study : Evaluation of the accuracy of fitting surface of orbital prosthesis constructed by photogrammetry scan.
Methods : An orbital prosthesis was made using photogrammetry scanning technique as a method for making digital facial impression to obtain facial 3D model using a high resolution professional camera with image processed through 3DF Zephyr open-source software and the other orbital prosthesis was made using a conventional impression for both the defect and contralateral healthy eye , then scanned with a Degree Of Freedom (DOF) extra oral desktop scanner. 3D models of the defect sites were printed from each scanning method to act as a master cast for the orbital prosthesis fabrication. Accuracy of orbital prosthesis fitting surfaces produced from the two techniques in comparison with a facial scan as a reference scan was assessed through deviation analysis using metrology grade software (Geomagic Control X ).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- photogrammetry scan to the defect and healthy sites | Other | Other: Photogramety Orbital ProsthesisCapture photographs of the face including the defective site by profesional camera |
| 2- Digital scan of a conventional impression to the defect and healthy sites | Other | Other: Conventional impression prosthesisDigital scan of a conventional impression to the defect and healthy sites, the impression was taken using silicone rubber impression material, to obtain 3D virtual model using an extraoral desktop scanner. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Unilateral orbital defect.
- Complete healing of the defect site with no open wound.
- At least 1 year passed after the last chemo or radiotherapy dose in patients who receiving this type of treatment
Key exclusion criteria (2 listed)
- Patient under chemo or radiotherapy due to presence of active tumor.
- Patient with unhealed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photogramety Orbital ProsthesisUsing 2D photographs to abtain 3D model of orbital defect anatomy | Other | 1- photogrammetry scan to the defect and healthy sites |
| Conventional impression prosthesisConventional impression to an orbital defect then scaning the impression using desktop scanner | Other | 2- Digital scan of a conventional impression to the defect and healthy sites |
Primary outcome
Accuracy of fitting surface of orbital prosthesis
Time frame: Baseline or Day 1
Measurements of accuracy: Measuring surfaces mesh deviation between the two orbital prosthesis fitting surfaces obtained using two types of scanning methods and a reference facial scan obtained using creality raptor (CR) scanner. 1. The STL file of the facial scan and the STL files of the two orbital prosthesis fitting surfaces were imported separately to the metrology grade software program( Geomagic control x) . 2. The STL file of the facial scan was selected and considered to be the reference data , and the STL files of the prosthesis fitting surfaces was selected and considered to be the measured data . 3. The STL file of the measured data was manually superimposed onto the STL file of the reference data . 4. A color surface map appeared on the reference data which indicate the directional mesh deviation result between the superimposed scans . 5. The color map scale was adjusted .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. for the patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photogramety Orbital Prosthesis and Conventional impression prosthesis in people with Orbital Deformity, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of fitting surface of orbital prosthesis (time frame: Baseline or Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.