Anophthalmos; AcquiredNCT04464109
Comparative Motility of Alloplastic Orbital Implants
A study testing Evisceration with orbital implantation in people with Anophthalmos; Acquired and Evisceration; Traumatic, Eye, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration . Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anophthalmos; Acquired, Evisceration; Traumatic, Eye
- What is being tested?
- Evisceration with orbital implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to Jun 2021
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are candidates for evisceration
Who cannot join
- Inability to provide independent, informed consent
- Significant preoperative motility abnormalities
Trial locations and contacts
1 site in 1 country.
Richard C Allen, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Mostafa Mohammed Mohammed Diab
Al Fayyum
Mostafa Mohammed M Diab, PhD, 01016737314, mmd11@fayoum.edu.eg
Richard C Allen, PhD, richardcutlerallen@gmail.com
About this study
Official title: Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration
This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .
Read the detailed description
Evisceration allows removal of the intraocular contents while preserving the sclera and normal extraocular muscle attachments. It is more advantageous than enucleation in patients in whom intraocular tumor is rules out.
Maximizing orbital volume and restoration of movement are important aspects of a successful surgical outcome.
Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm which don't adequately replace the volume leading to postevisceration socket syndrome. Therefore, various techniques have been described to expand the scleral cavity and allow placement of a large implant including anterior sclerotomies, posterior sclerotomies, and disinsertion of optic nerve.
Implant exposure is a terrible complication of evisceration with reported rates as high as 67%. Exposure of the implant can lead to infection, which usually mandates removal of the implant. Trying to minimize this risk, physicians intentionally place the implants posterior to the normal position of the globe. Some authors described placement of the implant posterior to posterior sclera which totally eliminated the risk of exposure.
However, this deep seating of the implant may have deleterious effects on its motility. It can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the implant moves it posterior to the pulleys that serve as the functional origins of rectus muscles. This relationship would be expected to alter the pulling directions of the rectus muscles after evisceration hindering effective implant motility.
In this trial the investigators will try to study the effect of posterior placement of the implants on its motility after evisceration.
- Being tested
- Evisceration with orbital implantation
- Keywords
- Evisceration, Orbital implant, Implant position, Implant motility
- Medical subject headings
- Anophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evisceration with orbital implantationProcedure or surgery
Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
| Study group | Role | What they receive |
|---|---|---|
| Retro-scleral placement of the implant | Active comparator | Surgical steps;
1. Two anterior scleral relaxing incisions
2. A 360° scleral incision around the optic nerve to disinsert it
3. Two posterior scleral relaxing incisions
4. The implant is inserted posterior to posterior scleral edges
5. The posterior sclera is closed then the anterior sclera is overlapped and closed.
6. The implant is completely seated in the intraconal space Receives: Procedure: Evisceration with orbital implantation |
| Intrascleral placement of the implant | Active comparator | Anterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space.
1. Anterior relaxing sclerotomies not reaching the optic nerve
2. A 360° scleral incision around the optic nerve.
3. The anterior sclera flaps are overlapped and closed
4. Part of the implant remains in the scleral shell, while the remaining part is sitting in the intraconal space. Receives: Procedure: Evisceration with orbital implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant motility
The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions
Measured: 6 months
Prosthesis motility
It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze.
Measured: 6 months
Secondary outcomes (1)
Volume augmentation
Exophthalmometry will be performed for all patients after fitting a prosthesis. Enophthalmos is to be graded from 1 to 4 (grade 1 = no postoperative improvement; grade 2 = improvement <2 mm but remained enophthalmos; grade 3 = improvement ≥2 mm but remained enophthalmos; and grade 4 = no enophthalmos) compared with unaffected side.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jul 2020
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anophthalmos; AcquiredStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohammed Mohammed Diab, Fayoum University Hospital
- Investigators
- Mostafa Mohammed M Diab, PhD, Principal investigator, Fayoum University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464109
- Sponsor's protocol ID
- R116/2020
- Status last verified
- Aug 2020
- First submitted
- 5 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available upon reasonable request from the corresponding author, after deidentification. The data are not publicly available due to their containing information that could compromise the privacy of research participants. Study protocol will be also available. Data will be available for researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration
- ClinicalTrials.gov ID
- NCT04464109
- Acronym / sponsor ID
- R116/2020
- Keywords
- Evisceration, Orbital implant, Implant position, Implant motility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .
Detailed description
Evisceration allows removal of the intraocular contents while preserving the sclera and normal extraocular muscle attachments. It is more advantageous than enucleation in patients in whom intraocular tumor is rules out.
Maximizing orbital volume and restoration of movement are important aspects of a successful surgical outcome.
Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm which don't adequately replace the volume leading to postevisceration socket syndrome. Therefore, various techniques have been described to expand the scleral cavity and allow placement of a large implant including anterior sclerotomies, posterior sclerotomies, and disinsertion of optic nerve.
Implant exposure is a terrible complication of evisceration with reported rates as high as 67%. Exposure of the implant can lead to infection, which usually mandates removal of the implant. Trying to minimize this risk, physicians intentionally place the implants posterior to the normal position of the globe. Some authors described placement of the implant posterior to posterior sclera which totally eliminated the risk of exposure.
However, this deep seating of the implant may have deleterious effects on its motility. It can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the implant moves it posterior to the pulleys that serve as the functional origins of rectus muscles. This relationship would be expected to alter the pulling directions of the rectus muscles after evisceration hindering effective implant motility.
In this trial the investigators will try to study the effect of posterior placement of the implants on its motility after evisceration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retro-scleral placement of the implant | Active comparator | Procedure: Evisceration with orbital implantationSurgical steps; 1. Two anterior scleral relaxing incisions 2. A 360° scleral incision around the optic nerve to disinsert it 3. Two posterior scleral relaxing incisions 4. The implant is inserted posterior to posterior scleral edges 5. The posterior sclera is closed then the anterior sclera is overlapped and closed. 6. The implant is completely seated in the intraconal space |
| Intrascleral placement of the implant | Active comparator | Procedure: Evisceration with orbital implantationAnterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space. 1. Anterior relaxing sclerotomies not reaching the optic nerve 2. A 360° scleral incision around the optic nerve. 3. The anterior sclera flaps are overlapped and closed 4. Part of the implant remains in the scleral shell, while the remaining part is sitting in the intraconal space. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who are candidates for evisceration
Key exclusion criteria (2 listed)
- Inability to provide independent, informed consent
- Significant preoperative motility abnormalities
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 |
|---|---|---|
| Evisceration with orbital implantationEvisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal. | Procedure or surgery | Intrascleral placement of the implant, Retro-scleral placement of the implant |
Primary outcome
Implant motility
Time frame: 6 months
The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions
Prosthesis motility
Time frame: 6 months
It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze.
1 secondary outcome
Volume augmentation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available upon reasonable request from the corresponding author, after deidentification. The data are not publicly available due to their containing information that could compromise the privacy of research participants. Study protocol will be also available. Data will be available for researchers who provide a methodologically sound proposal.
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.
Richard C Allen, PhD contact
Mostafa Mohammed M Diab, PhD principal investigator
Fayoum University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evisceration with orbital implantation in people with Anophthalmos; Acquired and Evisceration; Traumatic, Eye, run by Fayoum University Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 4 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mohammed M Diab, PhD (01016737314, mmd11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant motility (time frame: 6 months). 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 4 Aug 2020.