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

May 10, 2023 updated by: Hams Hamed Abdelrahman

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Ahmed K Farag, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

April 2, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • QoL_2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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