Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique

Not Applicable

Not yet recruiting

• Conditions: Occluar Prosthesis
• Interventions: Other: Digital occluar prosthesis; Other: Conventional occluar prosthesis

• Registration Number: NCT05584865
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18
• Study Start: 2022-11-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Digital occluar prosthesis	-
Group II	Conventional occluar prosthesis	-

Primary Outcome Measures

Name	Time	Method
Motility of ocular prosthesis	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.
Change in patient satisfaction	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
change in microbial analysis	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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt