Evisceration; Traumatic, Eye Clinical Trial
Official title:
Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration
NCT number | NCT04464109 |
Other study ID # | R116/2020 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | June 2021 |
This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Patients who are candidates for evisceration Exclusion Criteria: - Inability to provide independent, informed consent - Significant preoperative motility abnormalities |
Country | Name | City | State |
---|---|---|---|
Egypt | Mostafa Mohammed Mohammed Diab | Fayoum |
Lead Sponsor | Collaborator |
---|---|
Fayoum University Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant motility | The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions | 6 months | |
Primary | Prosthesis motility | It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze. | 6 months | |
Secondary | Volume augmentation | Exophthalmometry will be performed for all patients after fitting a prosthesis. Enophthalmos is to be graded from 1 to 4 (grade 1 = no postoperative improvement; grade 2 = improvement <2 mm but remained enophthalmos; grade 3 = improvement =2 mm but remained enophthalmos; and grade 4 = no enophthalmos) compared with unaffected side. | 6 months |
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