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Effect of drop AMEED on corneal repair after trans-PRK

Comparison of the effectiveness of Amniotic membrane extracted eye drop on repairing the corneal epithelial in patients after trans-epithelial photorefractive keratectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230306001
Enrollment
64
Registered
2023-03-06
Start date
2019-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Refractive error (Corneal disorders after trans-epithelial photorefractive keratectomy) Amnion, Photorefractive keratectomy, Wound healing, Refractive surgical procedures

Interventions

The case group was treated with AMEED (Lifecell Pharmaceuticals, Inc. Iran) and artificial tear drop (Iranian Parenteral &amp
Pharmaceutical Co. Iran) every four hours (conventional treatment with AMEED) up to three days post-surgery. It should be noted that both groups of patients have received routine and standard treatme
Pharmaceutical Co. Iran) (conventional treatment) was instilled every four hours within the same duration. It should be noted that both groups of patients have received routine and standard treatment
Experimental Drug,Placebo Comparator No treatment
Corneal epithelial repair by Amniotic membrane extracted eye drop after trans-PRK,Corneal epithelial repair without Amniotic membrane extracted eye drop after trans-PRK

Sponsors

Nanobiotechnology Research Center of Baqiyatallah university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age 20-50 years old 2. Patients with refractive problems whose Range of spherical equivalent is between -5 to -1.5

Exclusion criteria

Exclusion criteria: 1. History of using topical ophthalmic drugs in the past three months 2. Any history of eye surgery 3. Use of drugs that affect the tear profile (such as: blood pressure medication, rheumatism medication, anti-psychotic medication, etc.) 4. History of any eye diseases other than refractive disorders 5. Patients with diabetes history 6. Patients with drug allergy 7. History of any systemic diseases especially rheumatologic disease 8. Patients with anisometric eyes

Design outcomes

Primary

MeasureTime frame
size of corneal epithelial defects daily in both groups until the complete epithelial healing The patients' eyes are stained with fluorescein, and a photo of the stained part is taken with a photo slit device. The size of the defect in the picture will be determined by ImageJ software.

Secondary

MeasureTime frame
the corneal haziness 1st, 3rd, 6th months after surgery in both group measured the corneal haziness according to the standard evaluation ,pain measurement First, second and third day after surgery in both group The pain measurement was based on a 0-10 Likert scale.,conjunctival injection grading First, second and third day after surgery in both group using the Efron system,visual acuity 1st, 3rd, 6th months after surgery in both group using the Snellen chart

Countries

Iran

Contacts

Public ContactAlireza Ranaei

Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran

alirezaranaei@yahoo.com989383752427

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026