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Status unknownNCT05194891PEXUpdated Jan 31, 2022

Endothelial Changes in Pseudoexfoliation Syndrome

An observational study in Endothelial Cell Loss, Corneal, sponsored by Assiut University. Status unknown. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
50 Years to 75 Years
Sex
All
01

Study summary

this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.

Read the detailed 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.

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Conditions studied

  • Endothelial Cell Loss, Corneal
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In context

Corneal Endothelial Cell Loss

30 studies on the registry are indexed under Corneal Endothelial Cell Loss; 6 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 12 observational studies indexed under Corneal Endothelial Cell Loss.

Browse Corneal Endothelial Cell Loss studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

This prospective, non-randomized comparative ,interventional study was performed on 100 eyes of 100 patients who were divided equally into two groups (pseudoexfoliative and control). Patient who aged above50 years and with nuclear cataract grade II,III, clear cornea and endothelial cell density more than 1000\mm2 were included in this study. Also, patients with normal anterior chamber depth, dilatable pupil and with no active ocular disease or inflammation were included. Pseudoexfoliative patients who had glaucoma were excluded from the study.

Inclusion criteria

  1. Patient age is above50 years.
  2. Patient with nuclear cataract grade II, III.
  3. Clear cornea with no evidence of endothelial disease.
  4. Endothelial cell density more than 1000\mm2.
  5. Normal anterior chamber depth and dilatable pupil.
  6. No active ocular disease or inflammation.
  7. Pseudoexfoliative patients.

Exclusion criteria

Exclusion Criteria:

  1. History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
  2. Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
  3. Pseudoexfoliative glaucoma.
  4. Patients age below 50 years.
  5. Endothelial cell count less than 1000\mm2.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testSpecular Microscopy

    Phacoemulsification

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What researchers measure

Primary outcomes

  1. Study of corneal endothelial changes in pseudoexfoliation syndrome

    Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05194891
Lead sponsor
Assiut University
Responsible party
Shymaa Ahmed (Principal Investigator, Assiut University) — Principal investigator
First posted
Jan 18, 2022
Start date
Feb 1, 2022 (estimated)
Primary completion
Feb 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Jan 31, 2022

Study contacts

Shymaa Ahmed, Doctor
Contact
shymaa.sabet@yahoo.com
+20 106 319 4646
Hassan Shams Eldeen, Assis. Prof
Contact
hassanetal@yahoo.com
+20 114 409 0050
Shymaa Sabet, Doctor
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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