Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year

Background To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy. Design Prospective, non‐randomized, comparative study. Participants Sixty‐six Asian patients. Methods Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intra...

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Veröffentlicht in:Clinical & experimental ophthalmology 2013-08, Vol.41 (6), p.552-560
Hauptverfasser: Narayanaswamy, Arun, Perera, Shamira A, Htoon, Hla M, Hoh, Sek-Tien, Seah, Steve K, Wong, Tina T, Aung, Tin
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container_end_page 560
container_issue 6
container_start_page 552
container_title Clinical & experimental ophthalmology
container_volume 41
creator Narayanaswamy, Arun
Perera, Shamira A
Htoon, Hla M
Hoh, Sek-Tien
Seah, Steve K
Wong, Tina T
Aung, Tin
description Background To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy. Design Prospective, non‐randomized, comparative study. Participants Sixty‐six Asian patients. Methods Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. Main Outcome Measures The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. Results The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7–19.2) in the Ologen group and 26% (95% confidence interval 14.8–37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8–5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2–7.0 mmHg), respectively (P = 0.16). Needling with 5‐fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (
doi_str_mv 10.1111/ceo.12058
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Design Prospective, non‐randomized, comparative study. Participants Sixty‐six Asian patients. Methods Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. Main Outcome Measures The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. Results The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7–19.2) in the Ologen group and 26% (95% confidence interval 14.8–37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8–5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2–7.0 mmHg), respectively (P = 0.16). Needling with 5‐fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (&lt;10%) of adverse events in both groups, and there were no complications directly related to the Ologen implant. The blebs in the mitomycin C group had greater central area (P = 0.005), maximal area (P = 0.01) and height (P = 0.005), and were less vascular (P = 0.023) than the Ologen blebs. Conclusions At 1 year, the overall performance of Ologen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C. Eyes in the Ologen group required more frequent bleb needling procedures.</description><identifier>ISSN: 1442-6404</identifier><identifier>EISSN: 1442-9071</identifier><identifier>DOI: 10.1111/ceo.12058</identifier><identifier>PMID: 23279607</identifier><language>eng</language><publisher>Australia: Blackwell Publishing Ltd</publisher><subject>Absorbable Implants ; Aged ; Alkylating Agents - therapeutic use ; Cataract - complications ; Cataract - physiopathology ; Cataract - therapy ; Collagen ; collagen implant ; Confidence intervals ; Female ; Glaucoma ; Glaucoma - complications ; Glaucoma - physiopathology ; Glaucoma - surgery ; Glycosaminoglycans ; Humans ; Intraocular Pressure - physiology ; Lens Implantation, Intraocular ; Male ; Mitomycin - therapeutic use ; Ologen ; Phacoemulsification - methods ; Polymers ; Prospective Studies ; Surgery ; Trabeculectomy - methods ; Treatment Outcome ; Visual Acuity - physiology ; wound healing</subject><ispartof>Clinical &amp; experimental ophthalmology, 2013-08, Vol.41 (6), p.552-560</ispartof><rights>2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists</rights><rights>2012 The Authors. 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Design Prospective, non‐randomized, comparative study. Participants Sixty‐six Asian patients. Methods Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. Main Outcome Measures The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. Results The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7–19.2) in the Ologen group and 26% (95% confidence interval 14.8–37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8–5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2–7.0 mmHg), respectively (P = 0.16). Needling with 5‐fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (&lt;10%) of adverse events in both groups, and there were no complications directly related to the Ologen implant. The blebs in the mitomycin C group had greater central area (P = 0.005), maximal area (P = 0.01) and height (P = 0.005), and were less vascular (P = 0.023) than the Ologen blebs. Conclusions At 1 year, the overall performance of Ologen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C. 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Perera, Shamira A ; Htoon, Hla M ; Hoh, Sek-Tien ; Seah, Steve K ; Wong, Tina T ; Aung, Tin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4248-21b11f3c147773769c09e30cc86fb877228f2fcc488cbbe3c38a6821e1d1dddc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Absorbable Implants</topic><topic>Aged</topic><topic>Alkylating Agents - therapeutic use</topic><topic>Cataract - complications</topic><topic>Cataract - physiopathology</topic><topic>Cataract - therapy</topic><topic>Collagen</topic><topic>collagen implant</topic><topic>Confidence intervals</topic><topic>Female</topic><topic>Glaucoma</topic><topic>Glaucoma - complications</topic><topic>Glaucoma - physiopathology</topic><topic>Glaucoma - surgery</topic><topic>Glycosaminoglycans</topic><topic>Humans</topic><topic>Intraocular Pressure - physiology</topic><topic>Lens Implantation, Intraocular</topic><topic>Male</topic><topic>Mitomycin - therapeutic use</topic><topic>Ologen</topic><topic>Phacoemulsification - methods</topic><topic>Polymers</topic><topic>Prospective Studies</topic><topic>Surgery</topic><topic>Trabeculectomy - methods</topic><topic>Treatment Outcome</topic><topic>Visual Acuity - physiology</topic><topic>wound healing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Narayanaswamy, Arun</creatorcontrib><creatorcontrib>Perera, Shamira A</creatorcontrib><creatorcontrib>Htoon, Hla M</creatorcontrib><creatorcontrib>Hoh, Sek-Tien</creatorcontrib><creatorcontrib>Seah, Steve K</creatorcontrib><creatorcontrib>Wong, Tina T</creatorcontrib><creatorcontrib>Aung, Tin</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Clinical &amp; experimental ophthalmology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Narayanaswamy, Arun</au><au>Perera, Shamira A</au><au>Htoon, Hla M</au><au>Hoh, Sek-Tien</au><au>Seah, Steve K</au><au>Wong, Tina T</au><au>Aung, Tin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year</atitle><jtitle>Clinical &amp; experimental ophthalmology</jtitle><addtitle>Clin Experiment Ophthalmol</addtitle><date>2013-08</date><risdate>2013</risdate><volume>41</volume><issue>6</issue><spage>552</spage><epage>560</epage><pages>552-560</pages><issn>1442-6404</issn><eissn>1442-9071</eissn><abstract>Background To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy. Design Prospective, non‐randomized, comparative study. Participants Sixty‐six Asian patients. Methods Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. Main Outcome Measures The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. Results The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7–19.2) in the Ologen group and 26% (95% confidence interval 14.8–37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8–5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2–7.0 mmHg), respectively (P = 0.16). Needling with 5‐fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (&lt;10%) of adverse events in both groups, and there were no complications directly related to the Ologen implant. The blebs in the mitomycin C group had greater central area (P = 0.005), maximal area (P = 0.01) and height (P = 0.005), and were less vascular (P = 0.023) than the Ologen blebs. Conclusions At 1 year, the overall performance of Ologen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C. Eyes in the Ologen group required more frequent bleb needling procedures.</abstract><cop>Australia</cop><pub>Blackwell Publishing Ltd</pub><pmid>23279607</pmid><doi>10.1111/ceo.12058</doi><tpages>9</tpages></addata></record>
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source MEDLINE; Wiley Online Library All Journals
subjects Absorbable Implants
Aged
Alkylating Agents - therapeutic use
Cataract - complications
Cataract - physiopathology
Cataract - therapy
Collagen
collagen implant
Confidence intervals
Female
Glaucoma
Glaucoma - complications
Glaucoma - physiopathology
Glaucoma - surgery
Glycosaminoglycans
Humans
Intraocular Pressure - physiology
Lens Implantation, Intraocular
Male
Mitomycin - therapeutic use
Ologen
Phacoemulsification - methods
Polymers
Prospective Studies
Surgery
Trabeculectomy - methods
Treatment Outcome
Visual Acuity - physiology
wound healing
title Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year
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