Topical Insulin Versus Autologous Serum After Corneal Surgeries

NCT05331859 | Unknown Phase 1 DMC

• 1 other identifier: TIKRS
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to test whether use of topical insulin or autologous serum eye-drops can promote corneal epithelial healing following photorefractive keratectomy (PRK).

Conditions

Corneal Epithelial Wound

Keywords

lasik; PRK; topical insulin; autologous serum

Outcome Measures

Primary Outcomes (2)

• Duration for the corneal surface to completely re-epithelialize.

  up to 6 weeks

• Grade of postoperative corneal haze

  0, completely clear cornea; +0.5, barely visible corneal opacity; +1, reticular subepithelial opacities not interfering with visibility of fine iris details; +2, punctate or coalesced subepithelial opacities with mild obscuration of iris details; +3, confluent subepithelial opacities with moderate obscuration of the iris and lens; and +4, dense opacities with complete opacification of the stroma.

  6 weeks

Secondary Outcomes (2)

• Incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, sterile corneal ulcer, corneal melting, corneal neovascularization).

  6 weeks

• Best-corrected Visual Acuity improvement (Snellen, decimal)

  Before and after treatment completion, assessed up to 6 weeks

Study Arms (3)

conventional

PLACEBO COMPARATOR

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated only with conventional postoperative eye drops.

Drug: conventional

Insulin

ACTIVE COMPARATOR

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with topical insulin and conventional postoperative eye drops.

Drug: Insulin; Drug: conventional

Autologous serum eye drops

ACTIVE COMPARATOR

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with Autologous serum eye and conventional postoperative eye drops.

Drug: autologous serum (AS); Drug: conventional

Interventions

Insulin DRUG

Topical insulin drops will be prepared by diluting 1 unit of rapid-acting insulin per 1 mL of an artificial tear with a propylene glycol base. Drops will be preserved at low temperature (2ºC) and applied four times a day.

Insulin

autologous serum (AS) DRUG

Whole blood (20 ml) wll be procured by venipuncture, centrifuged at 1,500 revolutions per minute (relative centrifugal force of 25.15 × g) for 10 minutes. AS drops will be carefully prepared under a laminar airflow cabinet, and diluted with artificial tears (Systane ultra; Alcon) to 20%. AS drops will be prepared on the day of surgery and patients will be asked to keep AS drops refrigerated at about 4C.

Autologous serum eye drops

conventional DRUG

Topical moxifloxacin 0.5% (Vigamox; Alcon Laboratories) four times per day, artificial tears (Systane ultra; Alcon) every two hours, Dexamethasone 0.1% (Maxidex; Alcon Laboratories) four times daily for one month then fluorometholone 0.1% (Efemyo; Orchidia Laboratories) four times daily for another two to four weeks depending on refraction and haze level.

Autologous serum eye drops; Insulin; conventional

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• stable refraction of at least one year, normal corneal topography, and a minimum central corneal thickness of 500 μm.

You may not qualify if:

• unstable refraction, dry eye, blepharitis, corneal disease, glaucoma, systemic diseases including infectious and collagen vascular diseases, diabetes, and topographical evidence of keratoconus.

Sponsors & Collaborators

• Benha University: lead

Study Sites (2)

Ebsar Eye Centre

Banhā, Kalyobeya, 13512, Egypt

Location

Benha University

Banhā, 13512, Egypt

Location

Related Publications (3)

• Diaz-Valle D, Burgos-Blasco B, Rego-Lorca D, Puebla-Garcia V, Perez-Garcia P, Benitez-Del-Castillo JM, Herrero-Vanrell R, Vicario-de-la-Torre M, Gegundez-Fernandez JA. Comparison of the efficacy of topical insulin with autologous serum eye drops in persistent epithelial defects of the cornea. Acta Ophthalmol. 2022 Jun;100(4):e912-e919. doi: 10.1111/aos.14997. Epub 2021 Aug 18.

  PMID: 34407296 RESULT

• Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.

  PMID: 32951459 RESULT

• Akcam HT, Unlu M, Karaca EE, Yazici H, Aydin B, Hondur AM. Autologous serum eye-drops and enhanced epithelial healing time after photorefractive keratectomy. Clin Exp Optom. 2018 Jan;101(1):34-37. doi: 10.1111/cxo.12574. Epub 2017 Jul 18.

  PMID: 28718904 RESULT

MeSH Terms

Interventions

Insulin; Congresses as Topic

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Organizations; Health Care Economics and Organizations

Study Officials

• Taher Eleiwa, MD PhD

  Benha University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taher Eleiwa, MD PhD

CONTACT

+201069901973; taher.eleiwa@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 18, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: For 1 year after the publishing the results

Locations

EG (2)