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

Hams Hamed Abdelrahman

Status: Enrolling

Conditions: Orbital Deformity

Treatments: Device: Traditional drawing image; Other: Healthy controls; Device: Digitalized printed paper

Study type: Interventional

Funder types: Other

Identifiers

NCT05857189

QoL_2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Experimental group

Experimental group

Treatment:

Device: Digitalized printed paper

Control group

Active Comparator group

Treatment:

Device: Traditional drawing image

Healthy control group

Other group

Description:

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

Treatment:

Other: Healthy controls