Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses for Unilateral Eye Defect Patient Rehabilitation (Clinical Trial)

Conditions
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Orbital Deformity

Intervention / Treatment
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* Device: Digitalized printed paper
* Device: Traditional drawing image
* Other: Healthy controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Device: Digitalized printed paper<br>* Patients will receive a newly formed digitalized printed paper inserted into eyeglasses<br>|
| Active Comparator: Control group<br> | Device: Traditional drawing image<br>* Patients will receive eyeglasses that hold a traditional drawing image of the eye<br>|
| Other: Healthy control group<br>patients in this group will be observed as a normal reference group | Other: Healthy controls<br>* Patients will include volunteering participants with un defected eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Through study completion, average 6 months |