Application of biodegradable collagen matrix (Ologen™) implants in Dacryocystorhinostomy surgeries, a randomized clinical study.

BACKGROUND

To introduce and evaluate the application of Ologen implants in external Dacryocystorhinostomy (DCR) Surgeries.

METHODS

Prospective comparative randomized study was carried out on 60 patients coming to ophthalmology department, Menoufia University Hospitals. Patients included were suffering from primary acquired nasolacrimal duct obstruction with positive regurge test. Patients were randomly enrolled into two groups using alternating choice technique. Group A included 30 patients who had DCR surgery to treat the obstruction with Silicone tubes. Group B included 30 patients had a Dacryocystorhinostomy with Silicone tubes and Ologen implants.

RESULTS

Success rates as regard to relief of symptomatic epiphora were 86.7% in group A and 96.7% in group B and time of dye clearance test was 4.5 ± 0.6 min in group A and 3.9 ± 0.4 min in group B with p value 0.353 &0.001 consecutively. Apart from immediate mild post operative hemorrhage that was encountered in 2 cases in group B and 1 case in group A, there were no significant complications in both groups.

CONCLUSION

The current study shows that application of Ologen implants in external DCR surgeries may improve symptomatic epiphora without exposing the patients to more intra-operative or post-operative complications. To the best of our knowledge, the current study is the first one to use Ologen implants in external DCR surgeries. However, the follow-up period was relatively short and the sample size is relatively small and further work is required to verify the effect of Ologen in external DCR surgeries.

TRIAL REGISTRATION

Current Controlled Trials PACTR201711002809215 , and the date of registration is 29 November 2017. The trial is Retrospectively registered.