Orbital DeformityNCT05857189
Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses
A study testing Digitalized printed paper and Traditional drawing image in people with Orbital Deformity, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
A straightforward, user-friendly removable orbital prosthesis is a practical choice for effective rehabilitation in such patients with defective eyes. One of the essential elements for a good recovery is the retention of the prosthesis. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orbital Deformity
- What is being tested?
- Digitalized printed paper and Traditional drawing image
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 May 2023
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with an orbital defective eye (type I).
- Patients age more than 6 years.
- Patients with a unilateral enucleated eye.
- Skin-grafted orbital defects with a lack of natural retentive means either natural undercuts or retaining implants.
- Patients who are not prone to be received any prosthetic rehabilitation either for financial, age, or transportation problems of material that are needed for fabrication of prosthetic eye.
Who cannot join
- Patients with the bilateral enucleated eye.
- Patients with primary signs of skin inflammation, infection, or untreated local disease
- Patients refusing to wear any eyeglasses.
- Patients with ocular defects.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Ahmed K Farag, BDS, 01064557964, ahmedfarrag10@hotmail.com
Ahmed K Farag, BDS
About this study
Official title: Assessment of the Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses for Unilateral Eye Defect Patient Rehabilitation (Clinical Trial)
A straightforward, user-friendly removable orbital prosthesis is a practical choice for effective rehabilitation in such patients with defective eyes. One of the essential elements for a good recovery is the retention of the prosthesis. The prosthesis can be retained by using a spectacle frame, conformers, adhesives, osseointegrated implants, magnets, or buttons. Only osseointegrated prostheses in the maxillofacial region can use semi-precision attachments.
Read the detailed description
Aim: Using of eyeglasses with newly formed digitalized printed paper of mirrored photograph of an intact eye for orbital defected patients to restore the esthetic appearance. An evaluation of the quality of life for patients using temporalized eyeglasses with digitalized printed paper of mirrored photographs of a healthy eye.
- Conditions
- Orbital Deformity
- Being tested
- Digitalized printed paper, Traditional drawing image, Healthy controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitalized printed paperDevice
Patients will receive a newly formed digitalized printed paper inserted into eyeglasses
Traditional drawing imageDevice
Patients will receive eyeglasses that hold a traditional drawing image of the eye
Healthy controlsOther
Patients will include volunteering participants with un defected eye
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Digitalized printed paper |
| Control group | Active comparator | Not described Receives: Device: Traditional drawing image |
| Healthy control group | Other | patients in this group will be observed as a normal reference group Receives: Other: Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life score
each person's medical chart. Participants will complete the Arabic version of the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) before and after intervention.
The 26- item WHOQOL-BREF Arabic version consists of two overall items measuring general QOL and health condition and 24 items that are universally adopted for the WHOQOL-BREF in four domains: physical health, psychological health, social relationships, and environment. Each item will be rated on a 5- point Likert scale and the domain scores were transformed on a scale from 0 to 100
Measured: Through study completion, average 6 months
Patient behaviour toward using the newly designed eye glasses
The 14-item visual function questionnaire (VF-14), is based on 14 vision-dependent activities performed in everyday life, and the difficulty undertaking each activity is rated Scores range from 0 to 100, and higher scores represent better visual functioning and less difficulty to perform daily activities.
Measured: Through study completion, average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jan 2023
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
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.
- 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
- Crossover
- Model description
- Crossover between experimental and traditional groups after 2 weeks of lapse time. both groups will be compared to healthy control
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857189
- Sponsor's protocol ID
- QoL_2022
- Status last verified
- May 2023
- First submitted
- 2 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses for Unilateral Eye Defect Patient Rehabilitation (Clinical Trial)
- ClinicalTrials.gov ID
- NCT05857189
- Acronym / sponsor ID
- QoL_2022
- Conditions
- Orbital Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 12 May 2023 (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.
A straightforward, user-friendly removable orbital prosthesis is a practical choice for effective rehabilitation in such patients with defective eyes. One of the essential elements for a good recovery is the retention of the prosthesis. The prosthesis can be retained by using a spectacle frame, conformers, adhesives, osseointegrated implants, magnets, or buttons. Only osseointegrated prostheses in the maxillofacial region can use semi-precision attachments.
Detailed description
Aim: Using of eyeglasses with newly formed digitalized printed paper of mirrored photograph of an intact eye for orbital defected patients to restore the esthetic appearance. An evaluation of the quality of life for patients using temporalized eyeglasses with digitalized printed paper of mirrored photographs of a healthy eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover between experimental and traditional groups after 2 weeks of lapse time. both groups will be compared to healthy control
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Digitalized printed paper |
| Control group | Active comparator | Device: Traditional drawing image |
| Healthy control group | Other | Other: Healthy controlspatients in this group will be observed as a normal reference group |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with an orbital defective eye (type I).
- Patients age more than 6 years.
- Patients with a unilateral enucleated eye.
- Skin-grafted orbital defects with a lack of natural retentive means either natural undercuts or retaining implants.
- Patients who are not prone to be received any prosthetic rehabilitation either for financial, age, or transportation problems of material that are needed for fabrication of prosthetic eye.
Key exclusion criteria (4 listed)
- Patients with the bilateral enucleated eye.
- Patients with primary signs of skin inflammation, infection, or untreated local disease
- Patients refusing to wear any eyeglasses.
- Patients with ocular defects.
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 |
|---|---|---|
| Digitalized printed paperPatients will receive a newly formed digitalized printed paper inserted into eyeglasses | Device | Experimental group |
| Traditional drawing imagePatients will receive eyeglasses that hold a traditional drawing image of the eye | Device | Control group |
| Healthy controlsPatients will include volunteering participants with un defected eye | Other | Healthy control group |
Primary outcome
Change in quality of life score
Time frame: Through study completion, average 6 months
each person's medical chart. Participants will complete the Arabic version of the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) before and after intervention. The 26- item WHOQOL-BREF Arabic version consists of two overall items measuring general QOL and health condition and 24 items that are universally adopted for the WHOQOL-BREF in four domains: physical health, psychological health, social relationships, and environment. Each item will be rated on a 5- point Likert scale and the domain scores were transformed on a scale from 0 to 100
Patient behaviour toward using the newly designed eye glasses
Time frame: Through study completion, average 6 months
The 14-item visual function questionnaire (VF-14), is based on 14 vision-dependent activities performed in everyday life, and the difficulty undertaking each activity is rated Scores range from 0 to 100, and higher scores represent better visual functioning and less difficulty to perform daily activities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitalized printed paper and Traditional drawing image in people with Orbital Deformity, run by Hams Hamed Abdelrahman 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 5 inclusion and 4 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 12 May 2023. 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 Ahmed k Farag, BDS (01064557964, ahmedfarrag10@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life score (time frame: Through study completion, average 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 12 May 2023.