Evaluation efficacy of umbilical cord serum eye drops on corneal epithelium repair after trans-PRK refractive surgery in Baqiyatullah Hospital

Determination of the effect of fetal umbilical cord serum drops on the recovery time of damaged corneal epithelium after Trans-PRK surgery

In this study, 30 patients who meet the criteria for PRK surgery will be selected. Each patient will have two eyes, one of which will receive umbilical cord serum drops, and the other will receive sterile distilled water drops. The selection of the eye will be done randomly, and the drops will be coded and identical to ensure there is no difference between them. The patients will receive routine post-PRK treatment, and initial information will be recorded in a pre-designed questionnaire. The level of pain, epithelial defects, and conjunctival redness will be recorded on the first, second, fifth, and seventh days, and the patient’s vision, corneal haziness, and dry eye tests will be assessed in the first, third, and sixth months. Additionally, a confocal paraclinical test to evaluate the corneal surface nerves will be conducted before and six months after surgery.

Ophthalmology Department of Baqiyatullah Hospital

• Inclusion criteria: Age over 18 years indication for prk surgery Consent to participate in the study • Exclusion criteria: Failure to return for follow-up examinations after surgery

The intervention groups in this study are as follows: Intervention group: The eyes that will receive umbilical cord serum drops. Control group: The eyes that will receive sterile distilled water drops.

The primary outcome variable in this study is **the improvement in corneal epithelial defects** and **pain** on the first, second, fifth, and seventh days post-surgery. These variables are among the key factors evaluated to assess the effect of umbilical cord serum drops compared to sterile distilled water drops.

In this study, a total of 30 patients will be evaluated (one eye in the test group and the other in the control group, totaling 60 eyes). Both eyes of the patients will receive contact lenses and routine postoperative medications after PRK surgery. However, one eye will be treated with umbilical cord serum eye drops, while the other eye will receive sterile distilled water eye drops using identical vials (one drop every four hours). The selection of the eye receiving the umbilical cord serum eye drops will be determined through random allocation using a variable block method. The unit of randomization is each individual's eye.

The drops are made by the manufacturing company in a completely similar and coded way in advance so that there is no difference between the fetal cord serum drop and the placebo drop, and neither the examiner nor the patient knows in which eye the fetal cord serum drop was put and in which sterile distilled water.

Part of the data related to the results of the study will be shared for researchers to conduct future research

One year after the results are published

Researchers working in scientific and academic centers

It will be possible to access the data by specifying the source of information and preserving the intellectual rights of patients and study researchers

Ophthalmology Department of Baqiyatullah Hospital

After sending an email from the researcher to correspond of the study, the goals of the researcher will be checked for access to the data, and if approved, the information will be accessible in the Department of Ophthalmology of Baqiyatullah.