ologen Collagen Matrix useful in controlling fibrosis response from Strabismus surgeries, new study finds.

A new Brazilian case report follows a 68 year old patient suffering from convergent strabismus for 11 years, who then underwent strabismus surgery with ologen Collagen Matrix to control post-operation fibrosis, which limits the efficacy of the surgery itself. The surgery was successful and the authors concluded “It is not possible to affirm that the improvement was due to the use of ologen, but we believe it helped since duction limitation improved when the fibrosis was removed.”

Citation: dos Santos Martins, T., de Azevedo Costa, A., Centelhas, A. and dos Santos Martins, D. (2017). Use of biodegradable collagen-glycosaminoglycan copolymer matrix implant to reduce postoperative fibrosis in strabismus surgery. Taiwan Journal of Ophthalmology, 7(4), p.227.

Conflicts of interest: The authors reported no conflict of interest in the completion of this study.

New Brazilian study finds combined use of ologen and MMC in Phaco-NPDS to provide significant clinical advantages

In Brazil, 100 patients who went under Phaco-NPDS treatment from Jan 2011 to July 2017 were followed up for 12 months post-surgery to assess whether the group with both Mitomycin-C (MMC) and ologen Collagen Matrix application fares differently from the MMC-only group. While both adjuvants are individually known to be helpful in fibrosis prevention, relatively few studies exist on their co-application during surgery. The result – the double-adjuvant group demonstrated significantly higher absolute success rates, maintained lower IOPs, came back with fewer bleb failures and required fewer post-operative needling revisions when compared with the MMC only group. The authors conclude “the more favorable wound-healing response with concomitant use of ologen and MMC, compared with MMC alone, led to better IOP control at 12 months. ”

Citation: Guedes  et al. Use of a Collagen Matrix Implant as an Adjuvant in Combined Surgery Involving Phacoemulsification and Nonpenetrating Deep Sclerectomy. Journal of Glaucoma, 2019, 28(4):363-366.

Conflicts of interest: The authors reported no conflict of interest in the completion of this study.

ologen™ Collagen Matrix has been approved by Taiwan Food and Drug Administration (TFDA).

TFDA has officially approved ologen™ Collagen Matrix; this marks another chapter for ologen, along with more than 40 countries which are currently facilitating ologen treatments.

ologen™ Collagen Matrix Implantation is viable to assist Treatment of Scleromalacia after Periocular Surgery.

A long-term study conducted in South Korea with a total of 26 areas of 25 eyes in 25 patients were carried out. Post-operative follow-up of 8-12 months concluded that no eyes showed recurrence or specific complications related to Ologen such as implant extrusion or allergic reaction. Minor complications such as flap vessel engorgement and flap hypertrophy were easily treated.
Han et al. concluded that the combined surgery of may be an effective and safe procedure for the treatment of scleromalacia after periocular surgeries.

Citation: Han et al. Conjunctival Flap with Biodegradable Collagen Matrix Implantation for the Treatment of Scleromalacia after Periocular Surgery. Ocular Immunology & Inflammation, 2018; 00(00): 1-8.

Funding: The authors reported no conflict of interest in the completion of this study.

A RETROSPECTIVE STUDY DISCOVERED 41.7% HIGHER RATE OF COMPLETE SUCCESS OF OLOGEN-AUGMENTED AHMED GLAUCOMA VALVE IMPLANTATION THAN CONVENTIONAL METHOD.

This study included a total of 20 eyes of 20 glaucoma patients, who were followed for at least 1-year after undergoing AGV implantation. In 12 eyes of 12 patients, conventional AGV (CAGV) surgery was performed, while in 8 eyes of 8 patients, ologen-augmented AGV (OAGV) implantation was performed.
The rate of complete success was significantly higher in the OAGV group (50.0%) than in the CAGV group (8.3%).
Surgeries with ologen implantation show encouraging results for patients with refractory glaucoma, specifically with respect to the achievement of complete success and the reduction of the number of IOP-lowering medications during the early hypertensive phase.

Citation: Kim et al. Comparison of 1-year outcomes after Ahmed glaucoma valve implantation with and without ologen adjuvant. BMC Ophthalmology, (2018) 18:45.

Funding: The authors reported no conflict of interest in the completion of this study.

Subconjunctival implantation of ologen™ Collagen Matrix to treat ocular hypotony after filtration glaucoma surgery

A Recent 2-year retrospective study shows glaucoma patients in Japan benefiting from the usage of ologen™  collagen matrix in surgery. 7 patients with post-surgery ocular hypotony regained control of their eye pressure and glaucoma medication needs after intervention with collagen matrix assisted bleb revision.

ologen™ CM Patch Grafts Improve Ahmed Valve Treatment Success Rates by 127%

ologen™ CM Patch Grafts Improve Ahmed Valve Treatment Success Rates by 127%

 

According to a new 6-month Korean study published in the journal Investigative Ophthalmology & Visual Science, success rates of Ahmed Glaucoma Valve (AGV) surgeries soar and post-operative anti-glaucoma medication needs drop when said surgeries are performed in combination with biodegradable collagen patch grafts (commercially available as ologen™ CM).

Consisted of more than 90% atelocollagen, ologen™ CM is biodegradable and commercially available in dry form. It serves as a three-dimensional micro-scaffold that not only buffers the ocular aqueous flow but also encourages conjunctival fibroblasts to grow into its structure for healthy tissue formation.

Of the 43 AGV implantations performed, 22 were aided with patch grafts composed of biodegradable collagen. Those aided with the patch grafts see significantly healthier blebs, higher 6-monthtreatment success rate as well as lower dependence on anti-glaucoma medications for at least 6 months post-operation. These results can mean significantly improved life quality for many glaucoma patients undergoing AGV treatmentsand less drain on precious medical resource.

Aeon Astron Europe, the manufacturer of ologen™ CM is excited to learn of the new publication and believes it will help ologen™ CM in gaining approval for thepatch graft indication. The company expects the results of this study and others to be the incubator for more research interest to grow as well as more indication approvals to come.

Citation: Rho, S., Sung, Y., Ma, K., Rho, S., & Kim, C. (2015). Bleb Analysis and Short-Term Results of Biodegradable Collagen Matrix–Augmented Ahmed Glaucoma Valve Implantation: 6-Month Follow-up. Investigative Opthalmology & Visual Science Invest. Ophthalmol. Vis. Sci., 56(10), 5896-5896.

Funding: The authors reported no conflict of interest in the completion of this study

5-Year MMC vs. ologen™ CM Study finds the latter with 37% Higher Success Rates

5-Year MMC vs. ologen™ CM Study finds the latter with 37% Higher Success Rates

 

A new study published in the Journal of Ophthalmology in May finds that using collagen matrix implants (available commercially as ologen™ CM) in place of mitomycin C (MMC) can significantly increase the long-term (5 year) success rates of open-angle glaucoma treatment via trabeculectomy for Chinese patients.

A total of 63 eyes – a significantly high number of test subjects for trabeculectomy studies – received randomized treatments of either trabeculectomy with ologen™ CM or trabeculectomy with MMC. Eye pressure (IOP), eye tissue health, post-operative complications and other indicators were measured, analyzed and tracked regularly for five years, which makes it a milestone – the longest follow-up study on the subject to date.

Trabeculectomy is the current gold standard of glaucoma surgical treatments. Aeon Astron Europe, the manufacturer of ologen™ CM, is encouraged by the extremely positive results of this 5-year study. Large-scale and long-term studies such as this are important additions to an increasing body of evidence that collagen implants with anti-fibrotic functions may outperform anti-metabolite agent MMC in primary open-angle glaucoma treatments.

The company anticipates more research interests to ensue as multiple trabeculectomy-collagen matrix trials worldwide begin conclude in the near future. They are expected to yield the same powerful long-term care results in support of the increasing adoption of the collagen matrix.

Citation: Yuan, F., Li, L., Chen, X., Yan, X., & Wang, L. (n.d.). Biodegradable 3D-Porous Collagen Matrix (ologen™) Compared with Mitomycin C for Treatment of Primary Open-Angle Glaucoma: Results at 5 Years. Journal of Ophthalmology, 2015, 1-7.

Funding: The authors have no proprietary or commercial interest in any materials discussed in this paper.

A meta-analysis on ologen™ Collagen Matrix vs MMC in Trabeculectomy to be highlighted at the 2014 AGS Exhibit

A meta-analysis on ologen™ Collagen Matrix vs MMC in Trabeculectomy to be highlighted at the 2014 AGS Exhibit

A meta-analysis on ologen™ Collagen Matrix vs. MMC in trabeculectomy by Miao He et al. (2014) will be highlighted during the exhibit of AAE at the 2014 AGS, Washington DC at Omni Shoreham Hotel from Feb 27 – Mar 1. We sincerely welcome your visit at our booth T12.

The meta-analysis with the inclusion of the seven (7) RCTs including 227 eyes has shown that the WMDs (weighted mean difference) in IOP reduction between the ologen™ group and the MMC group in trabeculectomy were not significantly different in the follow-up period of 3m, 6m, 24m; the complete/qualified success rates (defined as post-op IOP < 21 mmHg w/o Rx; w/ or w/o Rx) of the two groups were also comparable at all time points. The meta-analysis reconciled the differences in the interpretations of the RCTs in terms of analyzing the absolute IOP vs. the reduction in IOP (which should be the case as a set of pre-/post-op IOP is considered paired data) by conducting a series of sensitivity tests, assessing for the review quality (kappa test), testing for publication bias (funnel plot and Egger’s test) and adjusting for study heterogeneity (a random effect model despite no Chi-square, I-square test findings) according to a good review practice (the Cochrane Reviewer’s Handbook and the PRISMA).

Further large-scale RCTs from the US and RCTs with follow-up up to 5 years from the EU are expected to be presenting at the “ologen™ Lunch Symposium” (Apr 3; Hall D5) at the 2014 WOC Tokyo from Apr 2 – Apr 5 along with the other topics of the novel application of ologen™ Collagen Matrix in bleb revision surgery and the repair of scleromalacia. We are also looking forward to meeting you at the April event.

New Horizons: “Novel Applications for ologen™ Collagen Matrix” at the 5th WGC, July 2013, Vancouver, Canada

New Horizons: “Novel Applications for ologen™ Collagen Matrix” at the 5th WGC, July 2013, Vancouver, Canada

The Aeon Astron sponsored symposium “New Horizons: Novel Applications for ologen™ Collagen Matrix” held at the fifth World Glaucoma Congress, Vancouver, met with great success.

The symposium featured the US experience with ologen™ Collagen Matrix (Dr David Godfrey, Glaucoma Associates of Texas, USA), the combined Ex-Press®-ologen™ CM technique (Dr. Steven Vold, Vold Vision, Arkansas, USA) and an overview of the surgical options for bleb revision surgery using ologen™ CM (Dr. Ronald Fellman, Glaucoma Associates of Texas, USA). Dr Nigar Hasanova of the National Center of Ophthalmology, Azerbaijan and Dr. Maria Moussalli, Hospital Italiano de Buenos Aires, Argentina presented case reports on respectively congenital glaucoma and non-penetrating deep sclerectomy (NPDS).

Dr. David Godfrey opened the symposium by reviewing the physical mechanisms of ologen™ Collagen Matrix which reduce scarring and maintain surgical success post trabeculectomy. He presented the surgical pearl relating to the trimming of the edge of the collagen matrix and placing it a couple of millimeters back from the limbus, in order to create a more posterior bleb when a fornix-based technique is implemented. Dr. Steven Vold of Vold Vision, Arkansas, shared the opinion that the collagen matrix may allow surgeons to shape the bleb appearance and create a healthy vascular bleb. Having an anti-scarring efficacy similar to MMC[1], the collagen matrix can be applied in combination with other glaucoma filtration devices, such as the Ex-Press® shunt to obtaina controlled outflow of aqueous humor and a minimally penetrating, simple, and precise surgical procedure.

In the retrospective series of 67 eyes treated at the Glaucoma Associates of Texas, where Dr. Godfrey and Dr. Fellman practice, the IOP of the trabeculectomy group with ologen™ CM (44 eyes) went from 20.5 (SD 7.2) mmHg pre-operatively to 11.6 (SD 2.9) mmHg at month 12 post-operatively. Throughout this 12-month follow-up period the patients showed a consistent and well controlled IOP with a stable visual acuity.In the combined phaco emulsification – trabeculectomy group with ologen™ CM (23 eyes), the IOP moved from 14.3 (SD 3.8) mmHg pre-operatively to 11.7 (SD 3.8) mmHg at month 12 post-operatively. At month 18, the cumulative proportion of surgical success was 91.1%*. According to Dr. Godfrey, with comparable results to the MMC-augmented trab, the collagen matrix augmented trab has the potential “to alleviate the long-term side effects typically associated with MMC”.

Dr. Ronald Fellman discussed the use of ologen™ Collagen Matrix in the treatment of refractory bleb dysesthesia and its options for bleb revision surgery. Whilst the traditional method is to revise and resurface the painful bleb using an autologous conjunctival patch (autologous conjunctival bleb resurfacing; ACBR), a second and more recent option could be bleb reduction with the use of ologen™ collagen matrix and subsequent conjunctival advancement. In comparison to ACBR, this method may avoid creating another conjunctival wound at the inferior part of the eye and, as some other surgeons also have proposed, may prevent bleb leak or further hypotony after bleb revision[2]. However, in some of his younger patients, Dr. Fellman, based on the individual’s anatomy and conditions, tends to excise the bleb and close the fistula with a patch graft followed by the implantation of a glaucoma drainage device. The ologen™ Collagen Matrix can be added to the tool kit of an ophthalmic surgeon and may be successfully applied in bleb revision, tube revision[3],[4] and as patch graft.

Dr. Nigar Hasanova, Azerbaijan, presented a number of case reports on combined trabeculotomy-trabeculectomy (CTT) with ologen™ Collagen Matrix in congenital glaucoma. The collagen matrix offers an attractive opportunity for pediatric surgeons to enhance the surgical success in young patients, where adjuvants such as MMC are usually not recommended. In 10 eyes of children aged between 1-14 months, the IOP was 40.4 (SD 6.87) mmHg preoperatively and 13.4 (SD 1.84) mmHg at the last post-operative visit (follow-up range: 3-6 months). The ologen® CM augmented CTT has received good results even in difficult cases including aniridia, neurofibromatosis type I, and CHED type II.

In conclusion, Dr. Maria Moussalli, Argentina, summarized the application of ologen™ Collagen Matrix in trabeculectomy and non-penetrating deep sclerectomy (NPDS). Using a variety of options to position the collagen matrix, Dr. Moussalli – as Dr. Vold – achieved good results by placing the matrix posterior to the (loosely closed) scleral flap. This, despite the more common surgical guideline to put the collagen matrix on top of the scleral flap. Applications and results obtained with ologen™ Collagen Matrix are constantly evolving and may lead to more novel surgical options, combinations and guidelines. For instance as an anti-scarring device in various eye surgeries and eye tissue repair, such as subscleral placement[5],[6],[7], subscleral-to-subconjunctival drainage placement of the material, scleral reinforcement etc.

* The surgical success is defined as a post-operative IOP < 18 mmHg with or without medication. The number of antiglaucoma medication went from 3.0 (SD 1.1) to 0.8 (SD 1.2) in the ologen® CM augmented trab group and from 3.2 (SD 0.7) to 0.2 (SD 0.4) in the ologen® CM augmented phacotrab group.


[1] Cillino S, Pace F Di, Cillino G, Casuccio A. Biodegradable collagen matrix implant vs mitomycin-C as an adjunct in trabeculectomy: a 24-month, randomized clinical trial. Eye 2011; 25(12):1598-606. doi: 10.1038/eye.2011.219.
[2] DietleinT S, Lappas A, Rosentreter A. Secondary subconjunctival implantation of a biodegradable collagen-glycosaminoglycan matrix to treat ocular hypotony following trabeculectomy with mitomycin C. Br J Ophthalmol, 2013 June; e-pub doi:10.1136/bjophthalmol-2013-303357
[3] Stirbu Oana, Jorge Vila. Tube Exposure Repair. Journal of Current Glaucoma Practice, 2012; 6(3): 139-142
[4] Rosentreter A, Mellein AC, Konen WW, Dietlein TS. Capsule excision and ologen implantation for revision after glaucoma drainage device surgery. Graefes Arch Clin Exp Ophthalmol2010; 248: 1319-24
[5] Tanuj D, Amit S, Saptorshi M, Meenakshi G. Combined Subconjunctival and Subscleral Ologen Implant Insertion In Trabeculectomy. Eye, 2013 May; E-pub. doi:10.1038/eye.2013.76
[6] Matthew S J, Sarkisian S, Nathan B, James M R. Initial experience using a collagen matrix implant (ologen) as a wound modulator with canaloplasty: 12 month results. 203 Glaucoma: surgery or wound healing – GL. 2012 ARVO; May 6-10, Ft. Lauderdale, USA