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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Photorefractive Keratectomy; Refraction Error
• Intervention / Treatment: Device: Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses; Device: Contact Bandage Lenses

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Hassan Abbas, MBBS; Phone Number: +923076781178; Email: abbas.hassan97@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Faisalābad, Punjab Province, Pakistan, 38000
      • Madina Teaching Hospital Faisalabad
      • Contact: Prof Dr Muhammad Zahid Siddiq, MBBS, FCPS; Phone Number: +923217878075; Email: drzahidfsd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known hypersensitivity to NSAIDs or ketorolac.
• Presence of any systemic diseases affecting wound healing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Participants who will receive Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses; Group A will receive ketorolac-soaked bandage contact lenses immediately after surgery. Postoperative pain will be assessed using Visual Analogue Scale at defined intervals. Epithelial healing will be monitored clinically until complete re-epithelialization. Any complications arising during postoperative period will be documented for each group.	Device: Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses; 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
Active Comparator: Group B Participants who will receive Non-Medicated Bandage Contact Lenses; Group B will receive standard non-medicated bandage contact lenses. Postoperative pain will be assessed using Visual Analogue Scale at defined intervals. Epithelial healing will be monitored clinically until complete re-epithelialization. Any complications arising during postoperative period will be documented for each group.	Device: Contact Bandage Lenses; Bandage contact lenses (BCLs) are routinely used after PRK to protect the corneal surface, reduce mechanical irritation from blinking, and promote epithelial healing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelial Healing	Time for epithelial healing	72 hours

Collaborators and Investigators

• Sponsor: Madina Teaching Hospital Faisalabad

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain Control; Ketorolac tromethamine; Non-Medicated Bandage Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No