CorneaNCT07693673
Corneal Topography and High Order Aberrations in Regular Contraceptive Pills
An observational study of Cornea and Refraction Error, run by Elshimaa A.Mateen at 1 site in Egypt.
Trial summary
Effect of regular usage of contraceptive pills on corneal topography and corneal high-order aberrations Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cornea, Refraction Error
- What is being tested?
- Hormonal Contraception and Combined Oral Contraceptive (COC)
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ophthalmology Department, Sohag University Hospital, Faculty of Medicine, Sohag University
Sohag, Sohag Governorate, 82524
About this study
Official title: Corneal Topography and High Order Aberrations in Women on Regular Contraceptive Pills
Effect of regular usage of contraceptive pills on corneal topography and corneal high-order aberrations
Read the detailed description
Comparing corneal topographic changes and corneal high-order aberrations for women planning to use oral contaceptive pills before and after the usage of the pills
- Conditions
- Cornea, Refraction Error
- Being tested
- Hormonal Contraception, Combined Oral Contraceptive (COC)
- Keywords
- cornea-contraceptive pills-high order aberrations
- Medical subject headings
- Corneal Diseases, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal ContraceptionOther
Effect of usage of hormonal contraceptive pills on corneal topography and corneal high-order aberrations
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral contraceptive pills users | Not described Receives: Other: Hormonal Contraception; Drug: Combined Oral Contraceptive (COC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in K1 (D)
Measured: Baseline and 1 year
Change in K2 (D)
Measured: one year
Change in Kmax (D)
Measured: one year
change in corneal thickness (um)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Oct 2024
- Primary completion30 Jan 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elshimaa A.Mateen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elshimaa A.Mateen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693673
- Sponsor's protocol ID
- Soh-Med-24-09-15PD
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No