Corneal Topography and High Order Aberrations in Regular Contraceptive Pills

NCT07693673 | Completed FDA Drug

• 1 other identifier: Soh-Med-24-09-15PD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of regular usage of contraceptive pills on corneal topography and corneal high-order aberrations

Conditions

Cornea; Refraction Error

Keywords

cornea-contraceptive pills-high order aberrations

Outcome Measures

Primary Outcomes (4)

• Change in K1 (D)

  Baseline and 1 year

• Change in K2 (D)

  one year

• Change in Kmax (D)

  one year

• change in corneal thickness (um)

  one year

Study Arms (1)

Oral contraceptive pills users

Other: Hormonal Contraception; Drug: Combined Oral Contraceptive (COC)

Interventions

Hormonal Contraception OTHER

Effect of usage of hormonal contraceptive pills on corneal topography and corneal high-order aberrations

Oral contraceptive pills users

Combined Oral Contraceptive (COC) DRUG

Participants who are prescribed combined oral contraceptive pills as part of routine clinical care will be observed. Corneal topography and tomography will be performed before starting treatment and after the follow-up period to evaluate changes in corneal parameters.

Oral contraceptive pills users

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women aged 18-40 years attending the Ophthalmology Department at Sohag University Hospital who are prescribed combined oral contraceptive pills by their gynecologist as part of routine clinical care. Participants will undergo corneal topography and tomography before starting treatment and after 1 year of oral contraceptive use.

You may qualify if:

• Female participants aged 18-40 years.
• Prescribed combined oral contraceptive pills as part of routine gynecological care.
• Willing to undergo corneal topography/tomography before starting treatment and after 1 year.
• No previous history of corneal disease or ocular surgery.
• Able to provide informed consent.

You may not qualify if:

• Keratoconus or suspected corneal ectasia.
• Corneal opacity, dystrophy, degeneration, or scarring.
• Previous ocular surgery or significant ocular trauma.
• Current contact lens use or recent contact lens use without adequate discontinuation period.
• Active ocular surface disease or severe dry eye.
• Glaucoma, uveitis, retinal disease, or other significant ocular pathology.
• Diabetes mellitus, autoimmune disease, thyroid disease, pregnancy, or lactation.
• Use of other hormonal therapy or systemic medications known to affect corneal parameters.

Sponsors & Collaborators

• Elshimaa A.Mateen: lead

Study Sites (1)

Ophthalmology Department, Sohag University Hospital, Faculty of Medicine, Sohag University

Sohag, Sohag Governorate, 82524, Egypt

Location

MeSH Terms

Conditions

Corneal Diseases; Refractive Errors

Interventions

Hormonal Contraception; Contraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics; Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 9, 2026
• Study Start: October 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)