Abstract
BackgroundBotulinum toxin (BTA) injection has been a standard treatment for thyroid eye disease (TED) related upper lid retraction (ULR), however, currently there is no consensus regarding the method of injection. Both transcutaneous (TC) and transconjunctival (TJ) injection of BTA has been reported to be successful. The aim of this study is to compare the changes between the lid parameters, the rate of complications and the difference in pain scores between the two groups.MethodA randomized controlled trial was carried out between 09/2017- 07/2019. 22 lids were randomized into either TC and TJ injection. Patients were blinded to receive either 2.5u of TC or TJ BTA injections and were followed up at 1, 3 and 6 months post injection by a masked investigator.Results12 and 10 lids were assigned ot the TC and TJ group respectively. At 1 month, the changes of PA were significant in the TJ group (-3.6±0.9, p=0.001), while the changes of MRD1 were significant in both groups (TC group: -1.67±1.74 (p=0.02), TJ group: -2.60±0.89 (p=0.003)). At 3 months, the change of MRD2 was only significant in the TJ group (-1.00±0.71, p=0.034). However, at 6 months, all lid parameter changes from baseline and between 2 groups were statistically insignificant. TC group had a significantly lower (-1.40±1.51, p=0.016) pain score. There was 1 case of diplopia and 1 case of ptosis in the TC group, while there were 2 cases of ptosis in the TJ group. ConclusionAt 1 month, the PA in the TJ group and the MRD1 in both groups showed statistically significant changes. At 3 months, the TJ group showed statistically significant changes in MRD2. The pain scores were significantly lower in the TC group. Although at 6 months, there were statistically insignificant changes between the 2 groups, the TJ group showed more promising results in 1 and 3 months, and the TC group has less pain. Hence, we hope to draw a consensus in the treatment of TED associated ULR by recommending the transconjunctival approach for BTA injections, however, we should expect it to be a more painful procedure. Trial registrationName of registry: HKU Clinical Trial Registry (HKUCTR)Trial registration number: HKUCTR-2306Date of registration: 08 Dec 2017URL of trial registry record: http://www.hkuctr.com/Investigator/Update/876c13c77a1a429e9283423b2d412ee1