Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery

January 4, 2023 updated by: Ahmed Helmy Mahmoud, Sohag University
An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This study will be conducted on patients who will undergo cataract extraction at Sohag university hospitals to evaluate the incidence of watery eyes in patients after phacoemulsification by one week , one month and three month.

  • Study Design: observational study.
  • Inclusion Criteria:

Patients with age-related cataract.

  • Exclusion Criteria:

    1. patients with watering of eyes or ocular surface diseases or watering of the eyes .
    2. patients with previous ocular surgeries.
    3. patients with glaucoma, uveitis, corneal or retinal pathologies.
  • Preoperative Evaluation:

Each patient will be subjected to the following:

Detailed history taking and full ophthalmological examination. Fluorescein dye disappearance test. Syringing and probing. Schirmer's test. Tear break up time test. Measurement of punctal diameter by AS-OCT.

  • Operative procedures:

    1. regional anesthesia.
    2. phaco technique : stop and shop.
    3. cumulative dissipated energy (CDE ) &fluid flow.

  • Follow-up regimen: will be as follows:

    1. patients will be examined after surgery on: 1st postoperative week, 1st month, 3rd month.

    2. The following will be recorded for each patient:

      1. symptoms of watery eyes, visual acuity, IOP, slit lamp examination.
      2. dye disappearance test.
      3. Schirmer's test.
      4. tear break up time test.
      5. anterior segment OCT.

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

50_ 80 year old Patients with age related cataract with no watery eyes subjected for phacoemulsification cataract surgery

Description

Inclusion Criteria:

  • patients with age related cataract.

Exclusion Criteria:

  • patients with watering of the eyes or ocular surface disease.

    • patients with previous ocular surgeries .
    • patients with glaucoma, uveitis, cornealor retinal pathologies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the incidence and possible causes of post phacoemulsification watery eye.
Time Frame: Five months
Patients are examined preoperatively and postoperatively by flourescein disappearance test, probing and syringing, schirmer's test,tear breakup time test and anterior segment optical coherence tomography to detect incidence and causes of post phacoemulsification watery eye.
Five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHMahmoud

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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