The Effect of Erythropoietin in the Treatment of Scleral Necrosis

Shahid Beheshti University of Medical Sciences

Status and phase

Invitation-only

Phase 3

Phase 2

Conditions

Conjunctival and Scleral Avascular Lesions

Treatments

Drug: Erythropoietin prescription

Drug: Prescription of placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05476042

14015

Details and patient eligibility

About

Patients with acute avascular lesions of the conjunctiva and sclera will be included in the study. Patients will undergo a complete eye examination including a slit lamp, intraocular pressure measurement, and fundoscopy with dilated pupil. At the same time, laboratory examination including measurement of fasting blood sugar (FBS) level, complete blood count (CBC) and systemic blood pressure will be performed. Patients will be randomly divided into three groups. The groups will receive sham drops (normal saline), erythropoietin 3000 units in normal saline, and erythropoietin 6000 units in normal saline every 6 hours respectively. Meanwhile, all patients will receive the usual treatments based on the cause of scleral necrosis.

Eye examinations will be done daily in the first week, every other day in the second week, and then twice a week until the complete recovery of avascular lesions. In each examination, with fluorescein staining, the size of the conjunctival epithelial defect will be determined. Also, the dimensions of the avascular area of the sclera will be determined. Other examinations include measurement of visual acuity and intraocular pressure, and the patient will be evaluated in terms of iris and retinal neovascularization. The photoslit lamp will be done before starting the study and then every week.

Complete healing of the lesion is defined by complete vascularization and epithelization of the ischemia site. After the complete recovery of conjunctival and scleral necrosis, the erythropoietin drop will be stopped and the examinations including blood pressure measurement, CBC, diff and FBS will be repeated.

Enrollment

60 estimated patients

Sex

All

Ages

10 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

patients with acute conjunctival and scleral avascular lesions resulting from ocular surgery (such as pterygium resection, glaucoma, strabismus, vitreous and retinal surgery), chemical and thermal burns, and collagen-vascular disease.

Exclusion criteria

a history of ocular surface tumors
a history of tumors in any part of the body
iris and retinal neovascularization for any reason
proliferative diabetic retinopathy
and systemic hypertension
if the sclera is severely thinned and the risk of perforation of the globe is imminent, the patient is excluded from the study.