Evaluation of the Effect of Exosome Therapy on Vision and Corneal Shape in Patients with Moderate and Severe Keratoconus

The Visual, Refractive and Tomographic Changes After Exosome Therapy in Moderate and Severe Keratoconus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120723010364N3

Enrollment

Registered

2025-12-29

Start date

2024-10-30

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus. ?????? ???????? ????? ?? ?? ???? ??? ? ????? ??? ?????? ????? ???? ?????? ? ???? ?? ?????? ??????? ??????????? ?????? ? ???? ??? ?????? ???????.

Interventions

Control group:Intracorneal ring segment implantation alone, performed according to the standard surgical protocol, without any additional biological intervention. Intervention group 1:Intracorneal rin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of moderate or severe keratoconus based on clinical examination and corneal imaging Eligibility for undergoing the study interventions Provision of written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: History of any corneal surgery in the study eye Presence of concomitant ocular diseases that may affect study outcomes Presence of systemic diseases that contraindicate the study intervention Pregnancy or breastfeeding Inability or unwillingness to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Change in best corrected visual acuity (BCVA), measured in LogMAR, from baseline to the end of follow-up. Timepoint: Primary outcomes are measured at two time points:At baseline (before the intervention)At the end of the study follow-up period. Method of measurement: Visual acuity of the participants is measured using the Snellen visual acuity chart.;Change in maximum keratometry (Kmax), measured by corneal tomography, from baseline to the end of follow-up. Timepoint: Primary outcomes are measured at two time points:At baseline (before the intervention)At the end of the study follow-up period. Method of measurement: Corneal tomographic parameters are measured using a Scheimpflug-based corneal tomography device.;Refractive errors of the eye are assessed by measuring spherical power, cylindrical power, and astigmatic axis, and their changes are evaluated to determine the effectiveness of the intervention. Timepoint: EnglishRefractive errors of the eye are measured at baseline (before the intervention) and during post-intervention follow-up visits according to the study protocol. Method of measurement: EnglishRefractive errors of the eye are measured using an autorefractometer and subjective refraction performed by an optometrist or ophthalmologist.	—

Measure

Time frame

Change in best corrected visual acuity (BCVA), measured in LogMAR, from baseline to the end of follow-up. Timepoint: Primary outcomes are measured at two time points:At baseline (before the intervention)At the end of the study follow-up period. Method of measurement: Visual acuity of the participants is measured using the Snellen visual acuity chart.;Change in maximum keratometry (Kmax), measured by corneal tomography, from baseline to the end of follow-up. Timepoint: Primary outcomes are measured at two time points:At baseline (before the intervention)At the end of the study follow-up period. Method of measurement: Corneal tomographic parameters are measured using a Scheimpflug-based corneal tomography device.;Refractive errors of the eye are assessed by measuring spherical power, cylindrical power, and astigmatic axis, and their changes are evaluated to determine the effectiveness of the intervention. Timepoint: EnglishRefractive errors of the eye are measured at baseline (before the intervention) and during post-intervention follow-up visits according to the study protocol. Method of measurement: EnglishRefractive errors of the eye are measured using an autorefractometer and subjective refraction performed by an optometrist or ophthalmologist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hesam Hashemian

Tehran University of Medical Sciences

h-hashemian@tums.ac.ir+98 21 7753 3939

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026