Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique

Study Overview
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Brief Summary
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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.

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

Conditions
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Occluar Prosthesis

Intervention / Treatment
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* Other: Digital occluar prosthesis
* Other: Conventional occluar prosthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br> | Other: Digital occluar prosthesis<br>* 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)<br>|
| Active Comparator: Group II<br> | Other: Conventional occluar prosthesis<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motility of ocular prosthesis | 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 | 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 | 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 |