Orbital Floor ReconstructionPhase 4NCT07789392
Patient-specific PEEK Implants for Post-maxillectomy Orbital Floor Reconstruction
A Phase 4 study testing Patient-specific PEEK implants in people with Orbital Floor Reconstruction and PEEK IMPLANTS, run by Alexandria University at 1 site in Egypt.
Trial summary
The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Orbital Floor Reconstruction, PEEK IMPLANTS, MAXILLECTOMY
- What is being tested?
- Patient-specific PEEK implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Feb 2026
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Unilateral invasive benign or malignant tumors of the maxilla that requires orbital floor resection.
- 3. Brown class III maxillectomy defects patients 2. Patients with immediate orbital floor reconstruction will be enrolled in this study.
Who cannot join
- Medically compromised patients contradicting operation.
- Delayed orbital floor reconstruction cases will be excluded.
- Bilateral cases will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patient-specific PEEK Implants for Post-maxillectomy Orbital Floor Reconstruction
The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery
- Conditions
- Orbital Floor Reconstruction, PEEK IMPLANTS, MAXILLECTOMY
- Being tested
- Patient-specific PEEK implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific PEEK implantsDevice
patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction by Patient-specific PEEK implants
| Study group | Role | What they receive |
|---|---|---|
| patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction | Experimental | Not described Receives: Device: Patient-specific PEEK implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enophthalmos analysis
On the axial cuts, at the level of a horizontal dissecting line (Baseline) was drawn joining the anterior tips of the lateral orbital margin bilaterally. The perpendicular distance from the top of the corneal bulge to this line was measured for both the affected and the contralateral globes. The difference in the measurement value between the normal and the affected orbit was used to conclude the presence or absence of enophthalmos, or proptosis of the orbit, using the equation (Globe Δ = Contralateral value-Ipsilateral Value). A reported difference between both globes of more than 2 mm is designated as enophthalmos
Measured: Immediately after the surgery
Orbital Volume Evaluation
An appraisal of the orbital volume will be performed as an objective evaluation modality for the assessment of the accuracy of orbital floor reconstruction after Brown class III maxillectomies in both groups.
A virtual orbital model of the reconstructed eye will be created using manual segmentation module in the 3D segmentation and image analysis software* for the following:
- Ipsilateral preoperative virtually reconstructed orbit.
- Ipsilateral immediate postoperative CT-scan of the reconstructed orbit.
- Contralateral preoperative and immediate postoperative orbit. The volume of the created orbital model will be automatically calculated and the mean value for each model will be calculated. In each group, efficiency of orbital floor reconstruction will be evaluated by comparing the postoperative value with the preoperative one and with the normal contralateral side.
Measured: Immediately after the surgery
Secondary outcomes (2)
Ocular postoperative complications
Postoperative ocular complications such as the presence of ectropion, entropion, scleral show, corneal abrasion, , which will be assessed by asking the patient to describe his vision in the six cardinal positions of gaze monocularly
Measured: 1 week postopreatively
Ocular motility and Diplopia
Ocular motility and diplopia were assessed using the "follow my finger" test. The test will be conducted by asking the patient to describe his vision in the six cardinal positions of gaze monocularly.
Measured: 1 week postopreatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2023
- Primary completion1 May 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital Floor ReconstructionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789392
- Sponsor's protocol ID
- 0772-09/2023
- Status last verified
- Jul 2026
- First submitted
- 22 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient-specific PEEK Implants for Post-maxillectomy Orbital Floor Reconstruction
- ClinicalTrials.gov ID
- NCT07789392
- Acronym / sponsor ID
- 0772-09/2023
- Conditions
- Orbital Floor Reconstruction, PEEK IMPLANTS, MAXILLECTOMY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 27 Aug 2026 (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.
The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction | Experimental | Device: Patient-specific PEEK implants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Unilateral invasive benign or malignant tumors of the maxilla that requires orbital floor resection.
- 3. Brown class III maxillectomy defects patients 2. Patients with immediate orbital floor reconstruction will be enrolled in this study.
Key exclusion criteria (3 listed)
- Medically compromised patients contradicting operation.
- Delayed orbital floor reconstruction cases will be excluded.
- Bilateral cases will be excluded.
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 |
|---|---|---|
| Patient-specific PEEK implantspatients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction by Patient-specific PEEK implants | Device | patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction |
Primary outcome
Enophthalmos analysis
Time frame: Immediately after the surgery
On the axial cuts, at the level of a horizontal dissecting line (Baseline) was drawn joining the anterior tips of the lateral orbital margin bilaterally. The perpendicular distance from the top of the corneal bulge to this line was measured for both the affected and the contralateral globes. The difference in the measurement value between the normal and the affected orbit was used to conclude the presence or absence of enophthalmos, or proptosis of the orbit, using the equation (Globe Δ = Contralateral value-Ipsilateral Value). A reported difference between both globes of more than 2 mm is designated as enophthalmos
Orbital Volume Evaluation
Time frame: Immediately after the surgery
An appraisal of the orbital volume will be performed as an objective evaluation modality for the assessment of the accuracy of orbital floor reconstruction after Brown class III maxillectomies in both groups. A virtual orbital model of the reconstructed eye will be created using manual segmentation module in the 3D segmentation and image analysis software* for the following: * Ipsilateral preoperative virtually reconstructed orbit. * Ipsilateral immediate postoperative CT-scan of the reconstructed orbit. * Contralateral preoperative and immediate postoperative orbit. The volume of the created orbital model will be automatically calculated and the mean value for each model will be calculated. In each group, efficiency of orbital floor reconstruction will be evaluated by comparing the postoperative value with the preoperative one and with the normal contralateral side.
2 secondary outcomes
Ocular postoperative complications
Time frame: 1 week postopreatively
Ocular motility and Diplopia
Time frame: 1 week postopreatively
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 9 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Orbital Floor Reconstruction
Not yet recruiting
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Orbital Fractures, Orbital Floor Fractures
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 Phase 4 study testing Patient-specific PEEK implants in people with Orbital Floor Reconstruction and PEEK IMPLANTS, run by Alexandria 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 2 inclusion and 3 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 9 Sep 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Enophthalmos analysis (time frame: Immediately after the surgery). The study lists 2 primary outcomes in all. 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 9 Sep 2026.