Interventional procedure overview of trabeculectomy with a biodegradable collagen matrix implant for glaucoma

Angmo D, Falera D, Singh A, et al. (2014) Outcomes of combined subconjunctival with subscleral ologen implant in glaucoma filtration surgery. Investigative Ophthalmology & Visual Science. 55, 3165

15 eyes had trabeculectomy with Ologen implant both subsclerally and subconjunctivally (double Ologen)

Follow-up 12 months.

 Trabeculectomy with implantation of biodegradable collagen implant both subsclerally and subconjunctivally appears to offer encouraging short-term results in terms of IOP control in eyes with primary adult glaucoma.

Double implant used in procedure

Cillino S, Pace FD, Cillino G et al. (2011) Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-months, randomized clinical trial. Eye; 25 (12):1598-606.

Parallel group RCT

N=40 (40 eyes) patients with uncontrolled IOP, POAG, PEXG,

trabeculectomy + Ologen (n=20) versus trabeculectomy (n=20)

follow-up 24 months

Results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate.

Study included in systematic review added to the summary of evidence.

Cillino S, Casuccio A, Pace FD et al. (2016) Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up. BMC Ophthalmology (2016) 16:24

RCT

40 patients with glaucoma (40 eyes)

trabeculectomy with MMC (n=20) or Ologen (n=20)

follow-up 5 years

Our extended follow-up results confirm that biodegradable collagen implant yields efficacy and long-term success rates quite similar to MMC, with at least equivalent safety.

Study included in systematic review added to the summary of evidence.

Elbably A, Rezq H, ElDakkak M et al. (2021) Efficacy and Safety of Sutureless Trabeculectomy with Using Porous Collagen (Ologen) in Management of Glaucoma Patients. Korean J Ophthalmol 2021;35(4):304-310

Prospective cohort study

N=25 eyes from 24 patients with advanced glaucoma (primary or secondary)

trabeculectomy with the Ologen

Follow-up 18 months

This technique can provide safety, effectiveness and short learning curve for ophthalmology trainees with lower incidence of perioperative and postoperative complications.

Small pilot study.

Larger studies included in summary of evidence.

El-Sayyad F, El-Saied HMA, Abdelhakim MASE. (2017) Trabeculectomy with ologen versus mitomycin c in juvenile open-angle glaucoma: a 1-year study. Ophthalmic Res; 57:230–8.

Prospective comparative study

20 patients (40 eyes) with medically uncontrolled juvenile OAG, Trabeculectomy with Ologen (20 eyes) versus trabeculectomy with MMC (20 eyes).

Follow-up 12 months

biodegradable collagen implant resulted in a lower long-term postoperative IOP, a better bleb morphology, and fewer complications. Our results suggest that biodegradable collagen implant may be a useful alternative to MMC in juvenile OAG

Study included in systematic review added to the summary of evidence.

Elwehidy AS, Bayoumi NHL, El Nokrashy A et al. (2022) Long-term outcomes of trabeculectomy with ologen implant versus combined viscotrabeculotomy-synechiolysis in uncontrolled uveitic glaucoma. Int Ophthalmol 42, 411–421.

Retrospective review

N=47 patients with uncontrolled uveitic glaucoma (UG)

Trabeculectomy with Ologen (n=23 eyes) versus combined viscotrabeculotomy-synechiolysis (VTS, n=24 eyes)

Follow-up 48 months.

Trabeculectomy with biodegradable collagen implant and visco-trabeculotomy-synechiolysis were equally effective in lowering IOP in uncontrolled UG. There was no statistically significant difference in the success rates between the 2 procedures.

Secondary glaucoma not POAG.

Marey HM, Mandour SS, Ellakwa AF. (2013) Subscleral trabeculectomy with mitomycin-C versus Ologen for treatment of glaucoma. Journal of Ocular Pharmacology and Therapeutics; 29(3):330-4.

parallel-group RCT

n=60 patients (60 eyes)

indications POAG, ACG, PEXG, uvetic glaucoma, uncontrolled pseudophakic glaucoma

trabeculectomy + Ologen (30 eyes) versus trabeculectomy + MMC (n=30 eyes)

follow-up 12 months

The use of the biodegradable collagen implant in sub-scleral trabeculectomy is comparable to the use of MMC with advantage of avoiding the potentially dangerous complications related to MMC use in the early (12 months) follow-up period.

Study included in systematic review added to the summary of evidence.

Maheshwari D, Gupta A, Ramakrishnan R (2012). Comparative study of MMC augmented trabeculectomy vs an Ologen implant in open angle glaucoma. Glaucoma-II Free Papers. 363-5.

parallel-group RCT

n=40 patients with OAG (40 eyes)

trabeculectomy + Ologen (n=20) versus trabeculectomy + MMC (n=20)

follow-up 12 months

Study reveals that trabeculectomy with implantation of a biodegradable collagen implant is a safe method without any serious complications but IOP lowering was more with trabeculectomy with MMC.

Study included in systematic review added to the summary of evidence.

He M, Wang W, Zhang X et al. (2014) Ologen Implant versus Mitomycin C for Trabeculectomy: A Systematic Review and Meta-Analysis. PLoS ONE 9(1): e85782.

Systematic Review and Meta-Analysis

7 RCTs (227 eyes)

The biodegradable collagen implant is comparable with MMC for trabeculectomy in IOP-lowering efficacy, reduction in the number of glaucoma medications, success rates, and tolerability. The results should be interpreted cautiously since relevant evidence is still limited.

More comprehensive and recent reviews added to the summary of evidence.

Mitra A, Krishnan R, Kadar MA et al. (2012) To compare the outcome, complications and management of complications of trabeculectomy with Ologen implant versus trabeculectomy with MMC. Glaucoma-II Free Papers. 330-5.

Parallel group RCT

N=64 (64 eyes) patients with uncontrolled OAG

trabeculectomy + Ologen (n=28) versus trabeculectomy + MMC (n=36)

follow-up 6 months

Study included in systematic review added to the summary of evidence.

Papaconstantinou D, Georgalas I, Karmiris E et al. (2010) Trabeculectomy with OloGen versus trabeculectomy for the treatment of glaucoma: a pilot study. Acta Ophthalmologica; 88(1):80-5.

Parallel group RCT

N=40 (40 eyes) patients with glaucoma

trabeculectomy + Ologen (n=20) versus trabeculectomy (n=20)

follow-up 6 months

In this pilot study, trabeculectomy with biodegradable collagen implant does not offer any significant advantages compared with trabeculectomy alone. There were no statistical differences between the 2 groups for complications.

Study included in systematic review added to the summary of evidence.

Perez CI, Mellado F, Jones A et al. (2017) Trabeculectomy combined with collagen matrix implant (Ologen). J Glaucoma; 26:54–58

Retrospective review

N=65 eyes of 58 patients with mainly POAG had trabeculectomy with Ologen implant.

Average follow-up 14.2 months.

Trabeculectomy surgeries with biodegradable collagen implant performed by the same surgeon were effective in lowering IOP with a low complication rate at mid-term follow-up.

Larger studies with longer follow-up included in the summary of evidence.

Ji Q, Qi B, Liu L, et al. (2015) Efficacy and safety of Ologen implant versus mitomycin C in primary trabeculectomy: A meta-analysis of randomized clinical trials. J Glaucoma 2015;24:e88–e94.

Systematic review and meta-analysis

6 studies (n=224)

trabeculectomy with Ologen implant versus trabeculectomy with mitomycin C (MMC)

Trabeculectomy with a biodegradable collagen implant is comparable to the use of MMC with a similar long-term success rate. However, it does not seem to offer significant advantages of avoiding the potential complications related to MMC.

More comprehensive reviews added to the summary of evidence.

Rosentreter A, Schild AM, Jordan JF et al. (2010) A prospective randomised trial of trabeculectomy using mitomycin C vs an Ologen implant in open angle glaucoma. Eye; 24(9):1449-57.

Parallel group RCT

N=20 (20 eyes) patients with uncontrolled IOP, OAG

trabeculectomy + Ologen (n=10) versus trabeculectomy +MMC (n=10)

follow-up 12 months

The complete success rate using trabeculectomy with the biodegradable collagen implant is lower than that achieved by trabeculectomy with MMC. However, the bleb morphology caused more problems in the MMC group.

Study included in systematic review added to the summary of evidence.

Rosentreter A, Gaki S, Cursiefen C et al. (2014) Trabeculectomy using mitomycin C versus an atelocollagen implant: clinical results of a randomized trial and histopathologic findings. Ophthalmologica; 231(3):133-40.

Parallel group RCT

N=30 (30 eyes) patients with uncontrolled IOP, OAG

trabeculectomy + Ologen (n=10) versus trabeculectomy +MMC (n=10)

follow-up 6 months

With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group. The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01

Study included in systematic review added to the summary of evidence.

Sarker D, Kumer B, Sadiq M. (2019) Outcome of trabeculectomy with Ologen versus Mitomycin C: A comparative prospective study in Bangladesh. European journal of ophthalmology. 29 (2), 183-188.

RCT

Patients with primary glaucoma Trabeculectomy with Ologen (52 eyes) versus MMC (55 eyes).

Follow-up 12 months

Trabeculectomy with biodegradable collagen implant appears to be safe and successful as trabeculotomy augmented with MMC, with no reported adverse reaction to biodegradable collagen implant .

22 patients with juvenile glaucoma were included.

Senthil S, Rao HL, Babu JG et al. (2013) Comparison of outcomes of trabeculectomy with mitomycin C vs. Ologen implant in primary glaucoma. Indian Journal of Ophthalmology; 61(7):338-42.

Parallel group RCT

N=33 (39 eyes) patients with uncontrolled POAG, PACG

trabeculectomy + Ologen (n=19) versus trabeculectomy +MMC (n=20)

follow-up 24 months

The success of trabeculectomy and complications were similar in both biodegradable collagen implant and MMC groups at the end of 6 months. The incidences of early post-operative complications were similar in the 2 groups, except hyphaema, which was significantly more in biodegradable collagen implant group (P = 0.02).

Study included in systematic review added to the summary of evidence.

Shalaby HS, Hashem NH. (2021) Trabeculectomy with OloGen versus Mitomycin C for the Treatment of Silicone Oil-Induced Glaucoma. Klin Monatsbl Augenheilkd

DOI 10.1055/a-1500-8230

RCT

40 eyes of 40 patients with silicone oil-induced glaucoma,

trabeculectomy with OloGen (20 eyes) versus trabeculectomy with MMC (20 eyes.

Follow-up 24 months

biodegradable collagen implant lowers IOP to a similar extent as MMC when combined with trabeculectomy for the treatment of silicone oil-induced glaucoma, and with comparable success rates. The rate of postoperative complications is similar for biodegradable collagen implantation and MMC.

Not POAG

Singh K, Bhattacharyya M, Mutreja A et al. (2018) Trabeculectomy with subconjunctival collagen implant in Indian eyes: Long-term results. Indian J Ophthalmol; 66:1429-34.

Case series

N=30 eyes of 28 patients with glaucoma had trabeculectomy with Ologen implant

Median follow-up 36 months

biodegradable collagen implant ‑augmented trabeculectomy is effective in controlling IOP over a long‑term follow up from minimal 3 to maximal 7 years (in 8 eyes). No untoward events jeopardizing bleb safety were noted at any time.

Larger studies included in table 2.

Shihadeh W, Massad I, Khader Y et al. (2017) Comparison of the outcomes of trabeculectomy with 5-fluorouracil versus Ologen implant in primary open-angle glaucoma. Ophthalmic Res 2017;58:94–98

Retrospective review

N=47 patients (58 eyes) with POAG underwent trabeculectomy using either Ologen (n=28 eyes) or 5-FU (n=30)

Follow-up 12 months

The efficacy and safety of trabeculectomy with 5-FU was similar to that with biodegradable collagen implant . Further studies with a larger number of patients and longer follow-up periods are needed.

Larger studies included in table 2.

Tanna AP, Rademaker AW, de Moares G et al. (2016) Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial.BMC Ophthalmology (2016) 16:217

RCT

N=94 (95 eyes) patients with mainly uncontrolled POAG.

Collagen matrix (45 eyes) versus MCC (48 eyes) in trabeculectomy (85 eyes) and combined phacoemulsification and trabeculectomy (10 eyes).

Follow-up 24 months

Use of the collagen implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC.

Few patients had combined phacoemulsification and trabeculectomy in both groups and outcomes were not reported separately.

Tanuj D, Amit S, M Saptorshi M et al. (2013) Combined subconjunctival and subscleral ologen implant insertion in trabeculectomy. Eye, 27, 889–897.

Case report

Trabeculectomy using Ologen implant under the subscleral flap and subconjunctival area

By placing the implant subsclerally, an additional advantage of lesser subscleral fibrosis might be obtained with better control of IOP.

Larger studies included in table 2.

Yuan F, Li L, Chen X. (2015) Biodegradable 3D-porous collagen matrix (Ologen) compared with mitomycin C for treatment of primary open-angle glaucoma: results at 5 years. J Ophthalmol; Article ID 637537, 7 pages

Parallel group RCT N=63 eyes of 44 patients with POAG

trabeculectomy with Ologen (n=21, 31 eyes) versus trabeculectomy + MMC (N=23, 32 eyes)

Follow-up 5 years

biodegradable collagen implant provides higher rates of surgical success compared with mitomycin C for patients with POAG undergoing trabeculectomy. It is safe, simple, and effective therapeutic approach for treating primary open-angle glaucoma.

Study included in systematic review added to the summary of evidence.

Zelefsky JR, Hsu WC and Ritch R(2008) Biodegradable collagen matrix implant for trabeculectomy. Expert Rev. Ophthalmol. 3(6), 613–617.

Review

Preliminary studies have demonstrated that the biodegradable collagen matrix is effective for use in trabeculectomy, although it may be associated with an increased risk of early postoperative hypotony. Future randomized, controlled trials should help determine its place in glaucoma surgery.

Review