Refraction ErrorNCT07705763
Comparison of Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses Versus Non-Medicated Bandage Contact Lenses on Postoperative Pain Control After Photorefractive Keratectomy
A study testing Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses and Contact Bandage Lenses in people with Refraction Error and Photorefractive Keratectomy, run by Madina Teaching Hospital Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Refraction Error, Photorefractive Keratectomy
- What is being tested?
- Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses and Contact Bandage Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2026to 31 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Known hypersensitivity to NSAIDs or ketorolac.
- Presence of any systemic diseases affecting wound healing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Madina Teaching Hospital Faisalabad
Faisalābad, Punjab Province, 38000
Prof Dr Muhammad Zahid Siddiq, MBBS, FCPS, +923217878075, drzahidfsd@gmail.com
About this study
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
- Being tested
- Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses, Contact Bandage Lenses
- Keywords
- Ketorolac tromethamine, Non-Medicated Bandage Contact Lenses, Postoperative Pain Control
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Tromethamine 0.5%-Soaked Bandage Contact LensesDevice
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 LensesDevice
Bandage contact lenses (BCLs) are routinely used after PRK to protect the corneal surface, reduce mechanical irritation from blinking, and promote epithelial healing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Contact Bandage Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain assessed using a standardized pain scoring system (e.g., Visual Analogue Scale) at 6, 24, 48, and 72 hours postoperatively.
Measured: 72 hours
Secondary outcomes (1)
Epithelial Healing
Time for epithelial healing
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refraction ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madina Teaching Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Abbas, Madina Teaching Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705763
- Sponsor's protocol ID
- 11
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No