Dataset Information

Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy.

ABSTRACT:

Introduction

Ocular pain is a common complication following photorefractive keratectomy (PRK). The level of patient satisfaction with current pain control strategies is not high. This study aims to assess the efficacy and safety of a novel regimen of preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops for post-PRK pain control.

Methods

In a contralateral eye study, 144 eyes of 72 patients who underwent bilateral transepithelial PRK (TransPRK) were stratified into experimental and control groups. The experimental group received preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops five times daily postoperatively until complete epithelial healing, while the control group received sodium hyaluronate 0.2% instead. The main outcome measures were pain scores assessed by the verbal rating scale and visual analogue scale (VRS, VAS), the corneal epithelial defect (CED) area, epithelial healing duration evaluated by slit-lamp biomicroscopy and anterior segment optical coherence tomography (AS-OCT), and endothelial cell density (ECD) measured before and 1 month after surgery.

Results

Pain scores assessed by VRS and VAS were significantly lower in the experimental group 8 h after surgery, and 1, 2, and 3 days postoperatively (P < 0.001). The mean CED area showed no significant differences between the two groups at different follow-ups (P value > 0.05). The corneal epithelial healing had a mean duration of 3.32 ± 0.47 days in both studied groups and was parallel in both eyes of each patient. In each group, 49 eyes (68%) and 72 eyes (100%) had a fully epithelialized surface on the third and fourth postoperative days, respectively. No significant changes were observed in the mean ECD 1 month following surgery in both groups (P value > 0.05).

Conclusion

Preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops are effective and safe in controlling early postoperative pain following TransPRK. The availability of the single-dose unit preparation can overcome the problem of topical anesthetic abuse.

Trial registration

ClinicalTrials.gov Identifier: NCT05733741.

SUBMITTER: Abdel-Radi M

PROVIDER: S-EPMC10640409 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy.

Abdel-Radi Mahmoud M Eldaly Zeiad Z Alattar Sara S Goda Islam I

Ophthalmology and therapy 20230904 6

<h4>Introduction</h4>Ocular pain is a common complication following photorefractive keratectomy (PRK). The level of patient satisfaction with current pain control strategies is not high. This study aims to assess the efficacy and safety of a novel regimen of preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops for post-PRK pain control.<h4>Methods</h4>In a contralateral eye study, 144 eyes of 72 patients who underwent bilateral transepithelial PRK (TransPRK) were stratified int ...[more]

PMID: 37665497

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Project description:ObjectiveTo evaluate the efficacy and safety of transcutaneous electrical stimulation (TES) for the prevention of dry eye after photorefractive keratectomy (PRK).DesignProspective, single-center, single-blinded, parallel group, placebo-controlled, randomized clinical trial.ParticipantsBetween February 2020 and October 2020, patients at the Samsung Medical Center scheduled to undergo PRK to correct myopia were screened and enrolled.MethodsThe participants in the TES group were instructed to use the electrical stimulation device (Nu Eyne 01, Nu Eyne Co) at the periocular region after the operation, whereas those in the control group were to use the sham device. Dry eye symptoms were evaluated preoperatively and postoperatively at weeks 1, 4, and 12 using the Ocular Surface Disease Index (OSDI) questionnaire, the 5-Item Dry Eye Questionnaire (DEQ-5), and the Standard Patient Evaluation for Eye Dryness II (SPEED II) questionnaire. Dry eye signs were assessed using tear break-up time (TBUT), total corneal fluorescein staining (tCFS), and total conjunctival staining score according to the National Eye Institute/Industry scale. The pain intensity was evaluated using a visual analog scale.Main outcome measuresPrimary outcomes were OSDI and TBUT.ResultsTwenty-four patients were enrolled and completed follow-up until the end of the study (12 patients in the TES group, 12 patients in the control group). Refractive outcomes and visual acuity were not different between the groups. No serious adverse event was reported with regard to device use. No significant difference in OSDI and SPEED II questionnaires and the DEQ-5 was observed between the groups in the 12th week after surgery. The TBUT scores 12 weeks after the surgery were 9.28 ± 6.90 seconds in the TES group and 5.98 ± 2.55 seconds in the control group with significant difference (P = 0.042). The tCFS and total conjunctival staining score were significantly lower in the TES group than in the control group at postoperative 4 weeks. Pain intensity at the first week was significantly lower in the TES group than in the control group by 65% (P = 0.011).ConclusionThe application of TES is safe and effective in improving dry eye disease after PRK.Financial disclosuresThe author(s) have no proprietary or commercial interest in any materials discussed in this article.

Project description:Purpose of the studyTo compare visual outcome, higher order aberrations (HOAs) of topography guided and Q value adjusted ablation in the fellow eye of patients undergoing photorefractive keratectomy (PRK) for the correction of myopia and myopic astigmatism.MethodsProspective randomized controlled interventional clinical study. The eyes of 52 patients undergoing PRK for myopia and astigmatism were included, that is, 104 eyes in total. In each patient, eyes were randomly allocated to group I: one eye received topography guided PRK using Contoura ablation software, or group II: the other eye received Q value adjusted PRK using Custom Q ablation software.Follow-upSix months.ResultsAt the end of 6 months, LogMAR UDVA was -0.04 ± 0.12 and -0.05 ± 0.11 (p = 0.688), while LogMAR CDVA was -0.06 ± 0.09 and -0.06 ± 0.1 in group I and group II, respectively (p = 0.972). Both groups showed a progressive oblate shift with time. This oblate shift was insignificantly less in group I by Topolyzer at 6mm, 15° and 30° at 6 months (p = 0.102, p = 0.138, p = 0.245, respectively). Topolyzer identified a significant difference between the change in coma and trefoil in both groups at 6 months (p<0.001 and p = 0.001, respectively). This was caused by the significant worsening of coma in group II (p<0.001) and the significant improvement of trefoil in group I (p = 0.007). No significant difference was found between groups in the change of ISV or ABR (p = 0.955 and 0.982, respectively). Ablation depth is a significant predictor of ΔQ at 6mm, 15° and 30° (p = 0.009, 0.039 and 0, respectively). No significant difference was found in the Strehl ratio or contrast sensitivity, although they were insignificantly better in group I (p = 0.785 and p = 0.745, respectively).ConclusionTG PRK and CQ PRK yielded similar results regarding UDVA, CDVA, MRSE, safety, predictability and contrast sensitivity. Both groups showed a progressive oblate shift, which was less in the TG group but the difference was statistically insignificant. TG PRK showed significantly improved trefoil HOA as compared to CQ PRK.

Dataset Information

Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy.

Introduction

Methods

Results

Conclusion

Trial registration

Publications

Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy.

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