Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05194891 |
Other study ID # |
Endothelial Changes in PEX |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 1, 2022 |
Est. completion date |
March 2023 |
Study information
Verified date |
January 2022 |
Source |
Assiut University |
Contact |
Shymaa Ahmed, Doctor |
Phone |
+20 106 319 4646 |
Email |
shymaa.sabet[@]yahoo.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
this study aimed to evaluate the corneal endothelial cell changes before and after
phacoemulsification in pseudoexfoliative patients relative to healthy adults.
Description:
Pseudoexfoliation syndrome (PEX) is an age related microfibrillopathy disorder characterized
by the deposition of greyish white flaky exfoliative material in ocular and extraocular
tissue. It commonly affects patients over 50 years old ((commonly in late 60s and 70s) with
prevalence range from 0.5% to > 30%, Although it occurs in virtually every area of the world,
a considerable racial variation exists in its incidence. It is relatively rare among African
Americans and Eskimos. Prevalence is high in the Sami people who are indigenous of northern
Europe. There is also a high prevalence in Arabic populations. It is also well known that
patients with PXF develop cataracts early in their lives. Phacoemulsification is a preferred
type of cataract surgery owing to fewer complications than other types. However, it still has
significant undesirable hazardous as Posterior capsular rupture, vitreous loss, Retinal
detachment, Cystoid macular oedema and Posterior capsule opacification. Also, it can enhance
loss of corneal endothelial cells, thickness and density that may result in corneal
decompensation and subsequent corneal transplantation. In patients with PXF, small pupils and
weak zonular support may enhance Phacoemulsification complications. Non-contact Specular
microscope is a non-invasive method for morphological analysis of corneal density of
endothelial cells, "size change" (Polymegathism), "hexagonal change" (pleomorphism).
Therefore, this technology plays an important role in preoperative evaluation, surgical
design and postoperative care.