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NCT Number: NCT07561398

Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects

After an initial period of standard treatment, they received further care aimed at helping the surface of the eye heal. Clear instructions were given on how to use and store the treatment properly. Patients were then monitored regularly over several months, with doctors checking their healing progress during follow-up visits. The study continued for a total of 24 weeks to observe how well and how quickly the eye surface recovered.

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Key information

Conditions

Persistent Corneal Epithelial Defect

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al Shifa Eye Trust Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location status: Recruiting

Location contact

Shama Khan, MBBS,FCPS

CONTACT

[email protected]

+92-3350928355

About this study

The area of the corneal epithelial defects will be evaluated using anterior segment photography of the cornea which will be performed after administration of fluorescein dye at a magnification of 10× using a camera attached to a slit-lamp microscope. The images will be analyzed with an image analysis system (ImageJ software) by a single observer to determine the epithelial defect area. The corneal epithelial defect will be graded from I through III. The patients will be randomly divided into two groups using computer generated random number. One half will be treated with Amniotic membrane grafts while other half will receive treatment with topical insulin drops administered every 6 hours till complete re-epithelization of corneal epithelial defects. Follow up will be done uptil 24 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Corneal epithelial defects for more than 2 weeks no improvement using standard treatment

Exclusion criteria

  • • Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders
  • Recent eye surgery within last 3 months
  • Hereditary corneal dystrophies
  • Active eye infections

Treatment and study plan

Topical insulin eye drops

Drug

Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects

Amniotic Membrane Graft

Procedure

Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects

Primary outcomes

  1. Cure rate

    Time frame: From time of randomization up to 24th week of followup.

    This will be the number of patients out of total number in each group completely cured of corneal epithelial defects

Secondary outcomes

  1. Mean time to healing

    Time frame: From time of randomization upto 24th week of followup

    This will be the mean time to complete healing in weeks from initiation of treatment until full epithelial closure as confirmed by lack of fluorescein staining on slit-lamp examination.

Study contacts

Contact information is provided by the study sponsor or research team.

Subha Mashaam Principal Investigator, MBBS

CONTACT

[email protected]

+92-340-6805428

Sponsors and collaborators

Lead sponsor

Al-Shifa Trust Eye Hospital

Other

Registry information

Official study title

Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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