Abstract
Purpose: :
Deep sclerectomy (DS) with the AquaFlow collagen implant has been shown to have a superior safety profile as compared to trabeculectomy; however its relative ability to lower intraocular pressure has been disputed. The objective of this study was to prospectively compare the efficacy and safety of DS with AquaFlow versus trabeculectomy .
Methods: :
Patients suitable for either DS with Aquaflow or trabeculectomy were prospectively randomized to one of the procedures. Intra–operative adjunctive antimetabolite therapy was used with consistent indications in each group. Post–operative antimetabolite use, needlings, argon suture–lysis and YAG goniopuncture were performed as indicated. Complete success was defined as achieving an IOP of less than 18 without the use of IOP lowering medication, while qualified success was defined as achieving an IOP of less than 18 with or without the use of topical IOP–lowering medication.
Results: :
A total of 118 eyes, 59 in each group were randomized with a mean follow–up time of 18 months. Mean preoperative IOP was 25.3 mmHg and 25.1 mmHg, and mean post–operative IOP was 12.3 mmHg and 12.5 mmHg in the DS and trabeculectomy groups respectively. The difference in pre and postoperative IOP between the groups was not significant (p = 0.56, p=0.49). The Kaplan Meier survival curves demonstrated a complete success of 75% and 72% for DS and trabeculectomy respectively, while qualified sucess was 96 and 94%. The incidence of shallow anterior chamber and hypotony (defined as less that 6 mmHg for greater than 2 weeks) was significantly lower in the DS. The incidence of other serious complications was low in each group preventing statistical analaysis, however the frequency of events did appear much lower in the DS group.
Conclusions: :
This is the first study to prospectively compare DS with Aquaflow versus trabeculectomy with consistent use of intraoperative antimetabolite therapy between groups as well as post–operative adjunctive procedure in each group. DS with AquaFlow was shown to be equally effective as compared to trabeculectomy over the study period and appears likely to have a superior safety profile.
Keywords: intraocular pressure