Skip to content

Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05584865
Enrollment
24
Registered
2022-10-18
Start date
2022-11-01
Completion date
2023-05-01
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occluar Prosthesis

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.

Interventions

OTHERDigital 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)

OTHERConventional 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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Motility of ocular prosthesisTime of insertionUsing 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 satisfactionTime of insertion and 3 monthsPatient 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 analysisTime of insertion and 3 monthsPatients 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

Countries

Egypt

Contacts

Primary Contactyassmin A Tahmawy, Msc
yasmin.gad@alexu.edu.eg01064680829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026