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

NCT07705763 | Not Yet Recruiting

• 1 other identifier: 11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refraction Error; Photorefractive Keratectomy

Keywords

Ketorolac tromethamine; Non-Medicated Bandage Contact Lenses; Postoperative Pain Control

Outcome Measures

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.

  72 hours

Secondary Outcomes (1)

• Epithelial Healing

  72 hours

Study Arms (2)

Group A Participants who will receive Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses

EXPERIMENTAL

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

Group B Participants who will receive Non-Medicated Bandage Contact Lenses

ACTIVE COMPARATOR

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

Interventions

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

Group A Participants who will receive Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses

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

Group B Participants who will receive Non-Medicated Bandage Contact Lenses

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Madina Teaching Hospital Faisalabad: lead

Study Sites (1)

Madina Teaching Hospital Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Dr Hassan Abbas, MBBS

CONTACT

+923076781178; abbas.hassan97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)