Post enucleation/evisceration
Conditions
Interventions
Participants will receive an impression of the eye socket (which is already
being done in complicated eye socket cases). Additionally, participants will be
provided with a photo of the healthy eye t
Sponsors
Amsterdam UMC
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 16 or older Able to understand the study information and instructions Patients already using an ocular prosthesis for at least 6 months Cases after enucleation, evisceration, or a prosthesis worn over the own blind eye
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Newly eviscerated or enucleated patients Socket pathology (cyst, infection, exposure, contraction) Not able to understand the study information and instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Well-being of the patient is measured by a validated quality of care and life questionnaire. Three domains will be assessed; wearing comfort, physical appearance and motility and psychosocial functioning. Each domain has 5 questions with answers from fully agree to fully disagree on a 5-point Likert scale. Outcomes per subdomain are obtained by summing all scores in that subdomain and can range from 5 to 25. The total score is obtained by summing the three subdomain scores and can range from 15 to 75. We choose for a difference of 15 points on the total score between the 3D designed prosthesis and the conventional prosthesis to be clinically relevant as non-inferiority margin. This number is chosen because the total number of questions is 15 and the average interquartile range is approximately 1 point for each question. Two prostheses (one conventional made and one 3D designed version) will be compared, the patients already wear the conventional and the newly designed prosthesis will be worn for 3 weeks. At the end of each period the participant is asked to fill out a questionnaire. The researcher will check (optional: telephone, whatsapp) with the patient that he/she actually fills out the form. Comparative analysis between 3D vs conventional scores will be done by estimating the 90% confidence interval of the difference. In case the lower bound of this confidence interval is above a score difference of -10, the 3D designed prosthesis is proven to be non-inferior compared to the conventional prosthesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial symmetry measurements will be done using a 3D laser scanner. Scans will be scored on defined prosthetic fitting parameters: - pretarsal show symmetry (mm), - superior sulcus volume symmetry (mm displacement), - upper lid position (MRD1) symmetry, - lower lid position (MRD2) symmetry, - horizontal palpebral fissure symmetry (mm); - lagophthalmos symmetry(mm with eyelids closed). Individual parameters will be compared using a paired t-test with significance at 0.05. By visual inspection of the results (histograms) we will check whether the data are normally distributed. If the results are not normally distributed a Wilcoxon signed-rank test will be used Motility of the artificial eye(s) is measured using an eyetracker -the eyetracker measures eyemovements in 4 directions of gaze (superior, inferior, nasal and lateral) - before the measurements the eyetracker is calibrated on both the healthy eye, and the artificial eye; The artificial eye is calibrated with help of a gimbal that holds the prosthetic eye, and which is directed at pre-set gaze directions with a laser pointer - the directions will be compared for each of the 4 directions between the conventional vs 3D designed prosthesis - all results will be expressed as the percentage of movement of the affected eye vs the normal healthy eye -Analysis will be done in SPSS. Comparison between the 3D designed prosthesis and the conventional produced prosthesis will be done using a paired t-test for each direction of gaze, and also for the sum of the four gaze directions. Individual directions, and the total sum will be compared and tested using a paired t-test with significance at 0.05. By visual inspection of the results (histograms) we will check whether the data are normally distributed. If the results are not normally distributed a Wilcoxon signed-rank test will be used. Subjective prosthesis opinion The prosthetic surface will be evaluated with 2D photographs using a 5-point li | — |
Countries
Netherlands
Outcome results
None listed