Trabeculectomy with Ologen®-Pilot

Trabeculectomy has been the gold standard procedure for the surgical treatment
of patients with glaucoma for several decades. To prevent scarring of the
filtering bleb, nowadays antimetabolites such as mitomycin-C are widely used as
an adjunctive during surgery. However, trabeculectomy with mitomycin-C in
general has been reserved for experienced glaucoma surgeons due to the possible
hazards of antimetabolites.
Recently, a new biodegradable porous collagen-glycosaminoglycan (CAG) copolymer
matrix implant (Ologen® collagen matrix (Aeon Astron Europe BV, Leiden, The
Netherlands) has been developed for glaucoma surgery. When placed over the
scleral flap, its porous structure should force conjunctival fibroblasts and
myofibroblasts to grow into the pores and secrete connective tissue in the form
of a loose matrix, reducing scar formation and wound contraction. The device
should completely degrade within 90-180 days after implantation.
Ologen® implantation may probably be a safe alternative for trabeculectomy with
mitomycin-C. Additionally, it may be cost-effective due to both a reduction in
primary surgery time as post-operative follow-up visits. Furthermore, an easier
operating technique could make glaucoma surgery more interesting for less
experienced surgeons. And lastly, less early and late onset bleb related
complications due to the use of antimetabolites can be expected.

The primary objective is the degree of IOP lowering after trabeculectomy with
adjuvant Ologen® implantation, in comparison to trabeculectomy with mitomycin-C.
Secondary objectives are peroperative and postoperative complications, and
postoperative bleb aspect after trabeculectomy with adjuvant Ologen®
implantation, in comparison to trabeculectomy with mitomycin-C.

Prospective intervention pilot study (with an external (historical) control
group), in which glaucoma patients who are scheduled for trabeculectomy with
mitomycine-C will be asked their consent for using an Ologen® implant instead
of applicating mitomycin-C as an adjuvant.

The intervention is trabeculectomy with implantation of an Ologen® implant as a
primary surgical procedure for patients with primary open-angle glaucoma. The
results will be compared with retrospective results of routine trabeculectomy
with mitomycin-C.

There are no extra risks to be expected. In contrast, mitomycin-C has the risk
for creating thin bleb walls, avascular blebs, and increased risk to infection,
blebitis and endophthalmitis. For Ologen® there is probably less risk to
infection, blebitis and endophthalmitis. Additionally, success rates may be
comparable, with no prior preparation required (compared to mitomycin-C), and
operation time may be saved.