Effect of Superficial Keratotomy on Reducing Postoperative Pain Following Conjunctival Flap Surgery: A Double-Blind Randomized Controlled Trial
Nasser Karimi1 *
- Eye Research Centre, School of Medicine, Iran University of Medical Sciences
Abstract: To determine if adding superficial keratotomy to the standard conjunctival flap method reduces postoperative pain.
Methods: In this double-blind randomized trial (ClinicalTrials.gov, NCT05494931), patients undergoing conjunctival flap surgery for prosthesis fitting, were assigned to either the control group (classical Gunderson method) or the intervention group (classical method plus superficial corneal neurotomy). Randomization used balanced quadruple blocks. Pain scores were measured using a visual analog scale (0-10) at 6, 24, and 48 hours postoperatively. The assessor was blinded to group assignment. Initial sample size was 16 patients, with an interim analysis planned after 9 patients. Successful prosthesis fixation, surgical complications, and need for reoperation were recorded during follow-up visits and calls.
Results: Pain scores were significantly lower in the intervention group (N=5) compared to the control group (N=4) at 6 hours (1.0 vs 8.0, P=0.02), 24 hours (1.0 vs 2.5, P=0.02), and 48 hours (0.0 vs 2.5, P=0.04). No significant differences in age, sex, education, ethnicity, previous ocular surgeries, or smoking history were found between groups. Median horizontal and vertical corneal diameters were similar (10.5 mm and 9 mm; P = 0.80 and P = 0.25, respectively). No flap retractions occurred during follow-up (median 7 months), but one control group patient developed small peripheral buttonholes that did not require surgical revision.
Conclusion: Superficial corneal neurotomy effectively reduces pain following conjunctival flap surgery, with no observed complications.
