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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16-70
SponsorAl-Shifa Trust Eye Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

• Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders

Recent eye surgery within last 3 months

Hereditary corneal dystrophies

Active eye infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: Group Topical InsulinActive comparator 1 intervention
Group B: Group Amniotic Membrane graftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cure rate

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

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

Secondary outcomes

1

Mean time to healing

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.

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

Other outcomes

Sponsors and contacts

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