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Comparison of Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses Versus Non-Medicated Bandage Contact Lenses on Postoperative Pain Control After Photorefractive Keratectomy

ConditionsRefraction ErrorPhotorefractive Keratectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-40
SponsorMadina Teaching Hospital Faisalabad

About this trial

Photorefractive keratectomy (PRK) is a well-established surface ablation procedure for the correction of refractive errors. Despite excellent visual and refractive outcomes, postoperative pain remains a significant concern, particularly during the first few days following surgery. This pain is primarily related to corneal epithelial removal, exposure of subepithelial nerve endings, and the subsequent inflammatory response. Effective pain management is therefore essential to enhance patient comfort, improve compliance with postoperative care, and increase overall surgical satisfaction. Therefore we will compare postoperative pain levels in patients undergoing PRK using ketorolac tromethamine 0.5%-soaked bandage contact lenses versus non-medicated bandage contact lenses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants selected to undergo photorefractive keratectomy for correction of refractive error after complete workup.

Participants willing to participate in the study after detailed explanation of the research purpose.

Disqualifiers

Known hypersensitivity to NSAIDs or ketorolac.

Presence of any systemic diseases affecting wound healing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses

    Device

    Soaking Bandage Contact Lenses in ketorolac prior to application may provide sustained drug release at the ocular surface, thereby enhancing postoperative pain control while reducing the need for repeated topical administration.Recent studies have suggested that ketorolac-soaked Bandage Contact Lenses may significantly reduce pain following Photorefractive Keratectomy without adversely affecting epithelial healing

  • Contact Bandage Lenses

    Device

    Bandage contact lenses (BCLs) are routinely used after PRK to protect the corneal surface, reduce mechanical irritation from blinking, and promote epithelial healing

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A Participants who will receive Ketorolac Tromethamine 0.5%-Soaked Bandage Contact LensesExperimental treatment 1 intervention
Group B: Group B Participants who will receive Non-Medicated Bandage Contact LensesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain

Postoperative pain assessed using a standardized pain scoring system (e.g., Visual Analogue Scale) at 6, 24, 48, and 72 hours postoperatively.

Time frame
72 hours

Secondary outcomes

1

Epithelial Healing

Time for epithelial healing

Time frame
72 hours

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Madina Teaching Hospital Faisalabad Status unavailable 38000, Faisalābad, Punjab ProvincePakistanPakistan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Madina Teaching Hospital Faisalabad

Lead sponsor

Source ClinicalTrials.gov

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