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Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03741153
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
gehad salah eldin galal, Assiut University

Brief Summary:
Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.

Condition or disease Intervention/treatment
Lens Diseases Device: slit lamp

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 14, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study group
includes patients who will be diagnosed with Pseudoexfoliation syndrome
Device: slit lamp
  1. Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin.
  2. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle.
  3. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules.
  4. presence of PXF material scattered on corneal endothelium.
  5. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.

control group
age matched controls who do not have Pseudoexfoliation syndrome
Device: slit lamp
  1. Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin.
  2. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle.
  3. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules.
  4. presence of PXF material scattered on corneal endothelium.
  5. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.




Primary Outcome Measures :
  1. the percentage of diabetic patients with pseudo-exfoliation syndrome [ Time Frame: 10 minutes ]
    slit lamp examination of all diabetic patients to get the percentage of those with pseudo-exfoliation syndrome



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who will be diagnosed with pseudo-exfolian syndrome
Criteria

Inclusion Criteria:

  • Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.

Exclusion Criteria:

  • Patients with previous intraocular surgery.

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Responsible Party: gehad salah eldin galal, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03741153     History of Changes
Other Study ID Numbers: PXSDM
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exfoliation Syndrome
Lens Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Iris Diseases
Uveal Diseases
Eye Diseases