BACKGROUND:Ocular massage is a common technique employed after trabeculectomy to aid filtration. This pilot study compares a novel ocular massage device (MD) with finger massage (FM) after trabeculectomy. The device provides the patient with audio feedback about correctly applied force, and the force applied can be customized for each patient. METHODS: A prospective, randomized study was performed comparing the effects of FM versus MD on intraocular pressure (IOP) and complication rates. All patients were given a standardized tutorial in ocular massage. The efficiency of their massage technique was evaluated at 1 week by having the patient perform the massage in front of the ophthalmologist, with IOP measurements taken before and after massage. Information on bleb morphology, IOP, ocular medications, and complications were recorded on a weekly basis. The patient perspective was recorded by questionnaire at 1 week, 1 month, and 3 months after initiation of the massage. RESULTS:Twenty-five patients were enrolled in the study, 12 randomly assigned to the FM and 13 to the MD groups. Patients in the MD group were much more confident that they were doing the massage correctly (p = 0.009) and reported a greater ease of use and lower pain scores. The mean difference in IOP in the 2 groups was not statistically significant in the first 3 weeks, and IOP after 3 months was statistically similar in both groups. Laser suture lysis was performed in 8 patients (66%) in the FM versus 6 (46%) in the MD group (p = 0.42). Wound leaks developed in 4 patients (3 in the FM group vs. 1 in the MD group, p = 0.32). INTERPRETATION: The massage device shows promise as an adjunctive tool in the postoperative management of trabeculectomies.
RCT Entities:
BACKGROUND: Ocular massage is a common technique employed after trabeculectomy to aid filtration. This pilot study compares a novel ocular massage device (MD) with finger massage (FM) after trabeculectomy. The device provides the patient with audio feedback about correctly applied force, and the force applied can be customized for each patient. METHODS: A prospective, randomized study was performed comparing the effects of FM versus MD on intraocular pressure (IOP) and complication rates. All patients were given a standardized tutorial in ocular massage. The efficiency of their massage technique was evaluated at 1 week by having the patient perform the massage in front of the ophthalmologist, with IOP measurements taken before and after massage. Information on bleb morphology, IOP, ocular medications, and complications were recorded on a weekly basis. The patient perspective was recorded by questionnaire at 1 week, 1 month, and 3 months after initiation of the massage. RESULTS: Twenty-five patients were enrolled in the study, 12 randomly assigned to the FM and 13 to the MD groups. Patients in the MD group were much more confident that they were doing the massage correctly (p = 0.009) and reported a greater ease of use and lower pain scores. The mean difference in IOP in the 2 groups was not statistically significant in the first 3 weeks, and IOP after 3 months was statistically similar in both groups. Laser suture lysis was performed in 8 patients (66%) in the FM versus 6 (46%) in the MD group (p = 0.42). Wound leaks developed in 4 patients (3 in the FM group vs. 1 in the MD group, p = 0.32). INTERPRETATION: The massage device shows promise as an adjunctive tool in the postoperative management of trabeculectomies.