Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique

October 14, 2022 updated by: Hams Hamed Abdelrahman

The Clinical Outcome of Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique (a Randomized Controlled Clinical Trial)

Different techniques of fabricating conventional custom-made ocular prosthesis were described. Traditional methods of custom fabricated ocular prosthesis had some limitations and take a long time, facial scanning and computed tomography will facilitate the full digital ocular prosthesis fabrication. Full digital ocular prosthesis is an innovated new technique to produce more accurate & more esthetic ocular prosthesis with less time consumed, however very few articles are available comparing between the full digital technique & the conventional one in manufacturing ocular prosthesis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

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
        • Alexandria Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Yassmin A Tahmawy, Msc

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have enough ocular bed to accommodate the ocular prosthesis.
  • At least 3 months after surgery to allow complete healing of the socket.

Exclusion Criteria:

  • Patients under steroid therapy or those under radio or chemotherapy.
  • Patients having eye lid deformity.
  • History of psychological disorder.
  • systemic disease.
  • eye infection.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Other: Digital occluar prosthesis
Each patient will receive the full digital fabricated ocular prosthesis. DICOM data from the Computerized Tomography (CT) will be imported into Materializes Interactive Medical Image Control System (MIMICS) software++++ tool for visualizing and segmenting medical images (such as CT and MRI)
Active Comparator: Group II
Other: Conventional occluar prosthesis
An accurate impression of the patient's eye socket will be obtained to prepare a suitable wax mod. The wax model will be flasked and processed into heat cured acrylic resin of the same colour of the sclera of the other healthy eye of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motility of ocular prosthesis
Time Frame: Time of insertion
Using Matlab R2016b software+. For each patient, photos of different eye positions will be taken, namely, the frontal, upper, lower, left, and right viewing positions.
Time of insertion
Change in patient satisfaction
Time Frame: Time of insertion and 3 months
Patient satisfaction will be evaluated by questionnaire based on the UK National Artificial Eye Questionnaire (NAEQ). The items that will be evaluated in the questionnaire include Time taken to adjust the prosthesis, Prosthesis cleaning frequency, Lubrication frequency, Comfort rating, satisfaction with prosthetic appearance, and satisfaction with prosthetic motility
Time of insertion and 3 months
change in microbial analysis
Time Frame: Time of insertion and 3 months
Patients will attend 2 visits (0,3 month), in which swab will be collected from the internal surface of the ocular prosthesis as well as from the anophthalmic cavit
Time of insertion and 3 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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • digital prosthesis_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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