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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-05-30

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.

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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.

Conditions

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Orbital Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover between experimental and traditional groups after 2 weeks of lapse time. both groups will be compared to healthy control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Digitalized printed paper

Intervention Type DEVICE

Patients will receive a newly formed digitalized printed paper inserted into eyeglasses

Control group

Group Type ACTIVE_COMPARATOR

Traditional drawing image

Intervention Type DEVICE

Patients will receive eyeglasses that hold a traditional drawing image of the eye

Healthy control group

patients in this group will be observed as a normal reference group

Group Type OTHER

Healthy controls

Intervention Type OTHER

Patients will include volunteering participants with un defected eye

Interventions

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Digitalized printed paper

Patients will receive a newly formed digitalized printed paper inserted into eyeglasses

Intervention Type DEVICE

Traditional drawing image

Patients will receive eyeglasses that hold a traditional drawing image of the eye

Intervention Type DEVICE

Healthy controls

Patients will include volunteering participants with un defected eye

Intervention Type OTHER

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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes