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NCT Number: NCT07366944

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

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Dry Eye Dry Eye Syndromes Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Lacrimal Apparatus Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • liver disoease
  • cardiac disease
  • renal disease

Treatment and study plan

exercise and limiting diet

Behavioral

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.

diet limitation

Behavioral

twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.

Primary outcomes

  1. schrimer test

    Time frame: it will be measured after 12 weeks

    it is a test for assessment dye dryness

Secondary outcomes

  1. Ocular surface disability index

    Time frame: It will be measured after 12 weeks

    it is a questionaire for assessment dye dryness

  2. dry eye scoring system

    Time frame: It will be measured after 12 weeks

    it is a questionaire for assessment dye dryness

  3. Tear film break-up time

    Time frame: It will be measured after 12 weeks

    it is a test for assessment dye dryness

  4. body mass index

    Time frame: it will be measured after 12 weeks

    it will be assessed on empty stomach and bowel

  5. wasit hip ratio

    Time frame: It will be measured after 12 weeks

    it will be assessed by dividing wasit circuference on hip circumference

  6. wasit circumference

    Time frame: It will be measured after 12 weeks

    it will be assessed by tape measure

  7. testesterone

    Time frame: It will be measured after 12 weeks

    it will be assessed in serum

  8. 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

  9. dehydroepiandrosterone

    Time frame: It will be measured after 12 weeks

    it will ne assessed in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Ismail

CONTACT

[email protected]

01031321109

Ali MA Ismail, lecturer

CONTACT

[email protected]

01005154209

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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