ABSTRACT
Purpose To evaluate and compare the efficacy and safety of the PreserFlo MicoShunt and the canaloplasty in patients with moderate to advanced glaucoma. Methods In this retrospective study, 300 patients with moderate to advanced glaucoma underwent either the implantation of the PreserFlo™ MicroShunt (group A) or a canaloplasty (group B). All patients underwent regular follow-up examinations in our department every two days, every two weeks, and every three, six, and 12 months postoperatively. Examinations included measurement of the best corrected visual acuity (BCVA), slit-lamp biomicroscopy of the anterior and posterior segments, intraocular pressure (IOP) measurement using Goldmann applanation tonometry, visual field perimetry, and measurement of the endothelial cell density (ECD). Efficacy was shown by the absolute and qualified success rates calculated with the Kaplan-Meyer analysis. Results In group A, IOP was significantly reduced at 12 months (13.37 ± 3.94 mmHg, p≤ 0.01) postoperatively in comparison to baseline (23.47 ± 8.39 mmHg). In group B, there was also a reduction in IOP at 12 months (14.32 ± 3.59 mmHg, p≤ 0.01) in comparison to the baseline (18.86 ± 5.82 mmHg). Comparing both groups, the IOP of patients who received the PreserFlo™ MicroShunt was significantly lower than the IOP of patients receiving canaloplasty after 12 months (p=0.049). Patients in both groups were treated with significantly fewer topical agents after 12 months (group A: baseline = 2.53±1.56; 12 months: 0.43 ± 0.83, p≤0.01; group B: baseline 2.62 ± 0.87; 12 months: 1.52 ± 0.99, p≤0.01). Patients receiving the PreserFlo™ MicroShunt applied significantly fewer topical agents than patients who underwent canaloplasty (p≤ 0.01). One year after surgery, the cumulative probability of absolute success was 81.33% in group A and 14.67% in group B. After one year, the cumulative probability of qualified success was 93.33% in group A and 82.00% in group B. Conclusion The PreserFlo™ as well as the canaloplasty offer many advantages and only a few disadvantages for patients with glaucoma. However, the respective patient's history and individual risk profile play an important role in the decision of the glaucoma specialist regarding the most appropriate surgical treatment for each patient. Patients with a high risk of conjunctival scarring and postoperative complications may benefit more from a canaloplasty, whereas patients who need a lower average IOP and show intolerance to any topical agents may require the PreserFlo™ implantation.
ABSTRACT
PURPOSE: To prospectively assess the effect of a single and regular application of either a cationic nanoemulsion of mineral oil (CN) or perfluorohexyloctane (F6H8) on the lipid layer of the tear film and higher order aberrations (HOA) in patients with Dry Eye Disease (DED). METHODS: Fifty-seven patients with a lipid layer thickness (LLT) ≤ 75 interferometric colour units (ICU) were included in the study. In group A (20 patients) the effect of a single drop of F6H8 or CN on HOA and LLT was assessed immediately after application and up to two hours later. For long term effects (Group B) 37 patients applied CN or F6H8 five times a day for 12 weeks. Measurement of LLT, HOA, non-invasive-tear-break-up-time (NIBUT) and meibography were assessed prior to as well as at 4 weeks and 12 weeks after initiation of treatment. Our study is registered in the "German Clinical Trials Register" under the trial number: DRKS00028696. RESULTS: CN led to an increase of the LLT from 46.8 ± 16.9 ICU to 76.3 ± 23.5 ICU (p = 0.021) and to an increase of HOA from 0.43 ± 0.06 µm to 0.48 ± 0.08 µm immediately after application (p = 0.027). There was no correlation between the increase of LLT and HOA (r = -0.04; p = 0.90). In group B an increase of LLT was observed in the F6H8 group from 45.8 ± 8.8 ICU at baseline to 66.7 ± 19.5 ICU at 12 weeks (p = 0.002). No changes of HOA were measured throughout the observation period in group B. After 12 weeks CN increased NIBUT from 9.9 ± 5.3 seconds to 15.5 ± 5.6 seconds (p = 0.04). F6H8 increased NIBUT from 12.4 ± 5.9 seconds to 16.9 ± 4.7 seconds (p = 0.02) after 12 weeks. CONCLUSION: CN leads to a short-term increase in LLT and HOA, but only immediately after application. In contrast F6H8 does lead to an increase of LLT after regular long-term use but has no effect on HOA. The regular application of lipid-based products does not seem to decrease the quality of vision as measured in HOA. Instead, CN and F6H8, both are able to stabilize the tear film after regular application.
