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Purpose: To comparatively evaluate in Indian eyes with coexisting cataract and primary open?angle glaucoma the outcome of mitomycin C (MMC) and Ologen implant as adjunctives in combined phacoemulsification with trabeculectomy. Methods: Eyes with primary open?angle glaucoma that underwent trabeculectomy and phacoemulsification with IOL implantation with either MMC application or Ologen implant between June 2019 and February 2020 were followed up for 12 months. Thirty?four eyes of 34 participants were studied. The primary outcome was intraocular pressure (IOP), and the secondary outcomes were the number of ocular hypotensives, best distance visual acuity (BDVA), and bleb morphology. Results: In 16 eyes treated with MMC and 18 eyes treated with Ologen implant, it was observed that the mean postoperative IOP (14.62 � 2.89 mm Hg with MMC and 14.56 � 4.14 mm Hg with Ologen implant) was not significantly different in both groups (P = 0.47). Number of ocular hypotensives and BDVA were also comparable between the two groups. However, bleb morphology was better with Ologen implantation. One eye in the MMC group developed hypotony which was conservatively managed. Conclusion: MMC and Ologen are both effective adjunctives in combined phaco?trabeculectomy. However, the Ologen implant provides better bleb health and safety
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@#AIM:To analyze the efficacy and safety of pterygium resection respectively combined with Ologen collagen matrix implantation and autologous conjunctival flap transplantation.METHODS:A total of 80 patients(87 eyes)with pterygium admitted to the hospital between January 2017 and January 2020 were selected, and randomly divided into observation group(40 patients, 44 eyes)treated with pterygium resection combined with Ologen collagen matrix implantation and control group(40 patients, 43 eyes)treated with pterygium resection combined with autologous conjunctival flap transplantation. The patients were followed up till 12mo after operation. The best corrected visual acuity, corneal astigmatism, surface asymmetry index(SAI), surface regularity index(SRI), corneal epithelial healing, pterygium recurrence and the incidence of complications were compared between the two groups. RESULTS:Visual changes of the two groups were similar at 6 and 12mo after operation(<i>P</i>>0.05). Corneal astigmatism, SAI and SRI were reduced in the two groups at 1 and 3mo after operation. The corneal astigmatismat 3mo after operation and SAI, SRI at 1 and 3mo after operation were significantly lower in the observation group than in the control group(all <i>P</i><0.05). The corneal epithelial healing rate in observation group at 1wk after operation was significantly higher than that in the control group(73% <i>vs</i> 46%, <i>P</i><0.05), and corneal epithelium of the two groups healed at 2wk after operation. No pterygium recurrence was observed in the two groups within 12mo after operation. The situation of pterygium recurrence was similar in the two groups at 6 and 12mo after operation(<i>P</i>>0.05). There was no significant difference in the incidence of complications between the two groups(7% <i>vs </i>14%, <i>P</i>>0.05).CONCLUSION:Both pterygium resection combined with Ologen collagen matrix implantation and pterygium resection combined with autologous conjunctival flap transplantation are effective in the treatment of pterygium, with equivalent safety. However, the former has more advantages in improving corneal astigmatism and regular shape of corneal wound.
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Resumo A matriz de colágeno Ologen TM é um novo agente antifibrótico composto por uma matriz porosa de atelocolageno tipo I e glicosaminoglicanos reticulados, que pode ser utilizado como uma alternativa para a modulação da cicatrização nas cirurgias. Por ser altamente poroso e biodegradável, este implante auxilia nos processos de reparação fisiológicos que ocorrem no tecido conjuntivo e epitelial da lesão, sem a formação de tecido fibrótico, o qual acarreta insucesso cirúrgico e elevação da PIO. A Trabeculectomia (TREC) é considerada a cirurgia padrão para o tratamento do glaucoma, no entanto as taxas de sucesso cirúrgico a médio e longo prazo estão relacionadas a cicatrização do sítio operatório, envolvendo principalmente o tecido conjuntival e tenoniano. O processo de cicatrização é divido em 4 fases principais: coagulativa, inflamatória, proliferativa e remodeladora, com uma série de cascatas químicas e fatores bioquímicos liberados na tentativa de restabelecer a hemostasia. Diversas pesquisas na literatura já demonstraram os efeitos benéficos na cicatrização ao utilizar a matriz de colágeno Ologen em cirurgias oftalmológicas, além das possíveis complicações. Os resultados dos atuais estudos com implante de Ologen para o tratamento de glaucoma são encorajadores e promissores. No entanto, ensaios clínicos randomizados futuros com seguimento a longo prazo são necessários para avaliarmos a segurança e a eficácia do novo implante na modulação da cicatrização, alcançando melhores taxas de sucesso cirúrgico.
Abstract The Ologen™ collagen matrix is a new antifibrotic agent composed of a porous matrix of type I atelocolagene and cross-linked glycosaminoglycans, which can be used as an alternative for the modulation of healing in surgeries. Because it is highly porous and biodegradable, this implant assists in the physiological repair processes that occur in the connective and epithelial tissue of the lesion without the formation of fibrotic tissue, which leads to surgical failure and IOP elevation. The Trabeculectomy (TREC) is considered the standard surgery for the treatment of glaucoma; however, the surgical success rates in the medium and long term are related to surgical site healing, mainly involving conjunctival and tenonian tissue. The healing process is divided into 4 main phases: coagulative, inflammatory, proliferative and remodeling, with a series of chemical cascades and biochemical factors released in an attempt to restore hemostasis. Since several researches in the literature have already demonstrated the beneficial effects on healing by using the Ologen collagen matrix in ophthalmic surgeries, in addition to possible complications. The results of current Ologen implant studies for the treatment of glaucoma are encouraging and promising. However, future randomized clinical trials with long-term follow-up are necessary to evaluate the safety and efficacy of the new implant in modulating healing, achieving better rates of surgical success.
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Humans , Male , Female , Adult , Middle Aged , Wound Healing , Trabeculectomy/methods , Mitomycin/therapeutic use , Absorbable Implants , Comparative Study , Glaucoma/surgery , Retrospective StudiesABSTRACT
Purpose: To report long-term safety and efficacy of trabeculectomy with collagen implant in Indian population. Methods: All cases of trabeculectomy with Ologen® Collagen Matrix implant performed over a 7-year period from May 2008 through April 2015 at a tertiary referral institute were reviewed. A total of 30 eyes of 28 patients were included in the study with two patients undergoing bilateral trabeculectomy. Outcomes measured included intraocular pressure (IOP) control, number of antiglaucoma medications used, bleb morphology, and complications/reoperations. Results: Trabeculectomy resulted in reduction in IOP from 36.46 to 11.65 mm Hg in the immediate postoperative period (day 1), a 68% decrease to 15.18 mm Hg at 84 months (58% decrease). The mean IOP reduction decreased over time from 63% in the first year to 55% after 5 years of follow-up. Fourteen eyes attained a follow-up of 5 years and eight eyes a follow-up of ?7 years. No sight-threatening complication such as hypotony, bleb leak, and bleb-related endophthalmitis was observed in our series, and only intervention required was 5-fluorouracil needling in one case. Conclusion: Ologen-augmented trabeculectomy is effective in controlling IOP over a long-term follow up from minimal 3 to maximal 7 years. No untoward events jeopardizing bleb safety were noted at any time. This modality is a viable alternative for patients with contraindications to use of antimetabolites.
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Purpose: To compare the safety and efficacy of trabeculectomy with Ologen implant vs. trabeculectomy with Mitomycin C (MMC). Materials and Methods: In a prospective, randomized, pilot study, 39 eyes of 33 subjects with medically uncontrolled primary glaucoma, aged 18 years or above underwent trabeculectomy either with MMC (20 eyes) or with Ologen implant (19 eyes). The primary outcome measure was cumulative success probability, defined as complete if the intraocular pressure (IOP) was > 5 and ≤ 21 mm Hg without anti-glaucoma medications or additional surgery and qualified if an IOP was > 5 and ≤ 21 mm Hg with or without anti-glaucoma medications. Results: Mean (± standard deviation) follow-up in Ologen group was 19.1 ± 8.1 months, and in MMC group was 18.0 ± 8.4 months. Mean IOP reduction at 6 months was significantly lower (P = 0.01) in the MMC group (11.9 ± 2.9 mm Hg) as compared to Ologen group (14.6 ± 2.7 mm Hg). However, at 12 months (P = 0.81) and 24 months (P = 0.32), the mean IOP was similar between the 2 groups. Complete success probability at the end of 6 months in Ologen group was 100% (95% confidence interval: 59.1 - 99.0) was similar (P = 0.53) to that in MMC group (93.8%, 95% CI: 63.2 - 99.1). The incidences of early post-operative complications were similar in the 2 groups, except hyphema, which was significantly more in Ologen group (P = 0.02). Conclusion: In this pilot study, the success of trabeculectomy and complications were similar in both Ologen and MMC groups at the end of 6 months.
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PURPOSE: Recently, biodegradable collagen matrix has been used as a possible substitute for anti-metabolite in trabeculectomy in order to control the responsiveness of the wound healing process. This paper reports a case of encapsulation of the biodegradable collagen matrix after trabeculectomy. CASE SUMMARY: We conducted a fornix-based trabeculectomy on a 58-year-old man with medically uncontrollable steroid-induced glaucoma. We implanted biodegradable collagen matrix onto the sclera flap beneath the conjunctiva. Immediately after the surgery, we observed a localized bleb with high elevation. In the three months of follow-up, the bleb became encapsulated, and an increase in intraocular pressure was noted. During the wound revision, encapsulated material surrounded by thick fibrous membrane was found and removed from the subconjunctival space, followed by biopsy. Biopsy results demonstrated that amorphous collagenous material was surrounded by spindle and inflammatory cells. CONCLUSIONS: It is important to note that the fibrous encapsulation of collagen material is a possible complication of biodegradable collagen matrix-augmented trabeculectomy.