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

NCT05857189 | Unknown

• 1 other identifier: QoL_2022
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Orbital Deformity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Experimental group

EXPERIMENTAL

Device: Digitalized printed paper

Control group

ACTIVE COMPARATOR

Device: Traditional drawing image

Healthy control group

OTHER

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

Other: Healthy controls

Interventions

Digitalized printed paper DEVICE

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

Experimental group

Traditional drawing image DEVICE

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

Control group

Healthy controls OTHER

Patients will include volunteering participants with un defected eye

Healthy control group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

Central Study Contacts

Ahmed k Farag, BDS

CONTACT

01064557964; ahmedfarrag10@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

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

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 12, 2023
• Study Start: January 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

EG (1)