PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes

January 17, 2026 updated by: Ali Mohamed Ali ismail, Cairo University

PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes in Obese Women

Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty females with PCOS, eye dryness , and obesity will asigned to group I or Group II, n=20 for each group. Both groups will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Cairo University
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PCOS women
  • obese class I
  • bilateral dryness of eye

Exclusion Criteria:

  • liver disoease
  • cardiac disease
  • renal disease

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group number 1
twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.
Behavioral: exercise and limiting diet
twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.
Active Comparator: group number 2
Twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.
Behavioral: diet limitation
twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
schrimer test
Time Frame: it will be measured after 12 weeks
it is a test for assessment dye dryness
it will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface disability index
Time Frame: It will be measured after 12 weeks
it is a questionaire for assessment dye dryness
It will be measured after 12 weeks
dry eye scoring system
Time Frame: It will be measured after 12 weeks
it is a questionaire for assessment dye dryness
It will be measured after 12 weeks
Tear film break-up time
Time Frame: It will be measured after 12 weeks
it is a test for assessment dye dryness
It will be measured after 12 weeks
body mass index
Time Frame: it will be measured after 12 weeks
it will be assessed on empty stomach and bowel
it will be measured after 12 weeks
wasit hip ratio
Time Frame: It will be measured after 12 weeks
it will be assessed by dividing wasit circuference on hip circumference
It will be measured after 12 weeks
wasit circumference
Time Frame: It will be measured after 12 weeks
it will be assessed by tape measure
It will be measured after 12 weeks
testesterone
Time Frame: It will be measured after 12 weeks
it will be assessed in serum
It will be measured after 12 weeks
LH:FSH ratio
Time Frame: It will be measured after 12 weeks
The LH (Luteinizing Hormone) to FSH (Follicle-Stimulating Hormone) ratio shows the balance between these reproductive hormones
It will be measured after 12 weeks
dehydroepiandrosterone
Time Frame: It will be measured after 12 weeks
it will ne assessed in serum
It will be measured after 12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali MA Ismail, lecturer, Cairo 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 (Actual)

December 5, 2025

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 5, 2026

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB000-14233-63

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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