Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: A prospective randomized clinical trial
To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation. Randomized controlled clinical trial. Sixty patients with refractory glaucoma. Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MM...
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| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 2004-06, Vol.111 (6), p.1071-1076 |
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| creator | Costa, Vital P Azuara-Blanco, Augusto Netland, Peter A Lesk, Mark R Arcieri, Enyr S |
| description | To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation.
Randomized controlled clinical trial.
Sixty patients with refractory glaucoma.
Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan–Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
After a mean follow-up of 12.3 months, Kaplan–Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan–Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (
P = 0.75 and
P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation. |
| doi_str_mv | 10.1016/j.ophtha.2003.09.037 |
| format | Article |
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Randomized controlled clinical trial.
Sixty patients with refractory glaucoma.
Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan–Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
After a mean follow-up of 12.3 months, Kaplan–Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan–Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (
P = 0.75 and
P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2003.09.037</identifier><identifier>PMID: 15177955</identifier><identifier>CODEN: OPHTDG</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Antibiotics, Antineoplastic - therapeutic use ; Biological and medical sciences ; Chemotherapy, Adjuvant ; Combined Modality Therapy ; Female ; Follow-Up Studies ; Glaucoma - drug therapy ; Glaucoma - surgery ; Glaucoma and intraocular pressure ; Glaucoma Drainage Implants ; Humans ; Intraocular Pressure ; Intraoperative Care ; Male ; Medical sciences ; Middle Aged ; Mitomycin - therapeutic use ; Ophthalmic Solutions ; Ophthalmology ; Prospective Studies ; Prosthesis Implantation ; Safety ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Surgery of the eye and orbit ; Survival Analysis ; Treatment Outcome</subject><ispartof>Ophthalmology (Rochester, Minn.), 2004-06, Vol.111 (6), p.1071-1076</ispartof><rights>2004 American Academy of Ophthalmology</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ophtha.2003.09.037$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15849254$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15177955$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Costa, Vital P</creatorcontrib><creatorcontrib>Azuara-Blanco, Augusto</creatorcontrib><creatorcontrib>Netland, Peter A</creatorcontrib><creatorcontrib>Lesk, Mark R</creatorcontrib><creatorcontrib>Arcieri, Enyr S</creatorcontrib><title>Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: A prospective randomized clinical trial</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation.
Randomized controlled clinical trial.
Sixty patients with refractory glaucoma.
Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan–Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
After a mean follow-up of 12.3 months, Kaplan–Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan–Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (
P = 0.75 and
P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation.</description><subject>Antibiotics, Antineoplastic - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy, Adjuvant</subject><subject>Combined Modality Therapy</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Glaucoma - drug therapy</subject><subject>Glaucoma - surgery</subject><subject>Glaucoma and intraocular pressure</subject><subject>Glaucoma Drainage Implants</subject><subject>Humans</subject><subject>Intraocular Pressure</subject><subject>Intraoperative Care</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mitomycin - therapeutic use</subject><subject>Ophthalmic Solutions</subject><subject>Ophthalmology</subject><subject>Prospective Studies</subject><subject>Prosthesis Implantation</subject><subject>Safety</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Surgery of the eye and orbit</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpNkU9v1DAQxS0EapfSb4CQL3BLsGM7sTkgrVZtQarEBbhajv-ws0riEDuVlgtfvV7tInGaOfzmzbx5CL2lpKaEth8PdZz3eW_qhhBWE1UT1r1AGyq4qnhH2Uu0KRitWt6Qa_Q6pQMhpG0Zv0LXVNCuU0Js0N-7EMAae8RmcjiZ4PMRx4CNO6yTzfDk8Qg5jkcLE95hty4w_cLb_egdfhjMauNo8E8zFA7GeTBTNhni9Alv8bzENPuzxlLU4wh_ypQdYCobB5wXMMMb9CqYIfnbS71BP-7vvu--VI_fHr7uto-Vb1STK9EaIh1lUtHOM-9YcFSSnve95FIwd2qC5FY4QZrWBNt3hEvX28ZyarlnN-jDWbdc9Xv1KesRkvVDudjHNemOKtUKIQv47gKufTGp5wVGsxz1v5cV4P0FMKnYCMWahfQfJ7lqBC_c5zPni60n8ItOFvxkvYOlfEW7CJoSfcpSH_Q5S33KUhOlS5bsGRcWlEg</recordid><startdate>20040601</startdate><enddate>20040601</enddate><creator>Costa, Vital P</creator><creator>Azuara-Blanco, Augusto</creator><creator>Netland, Peter A</creator><creator>Lesk, Mark R</creator><creator>Arcieri, Enyr S</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20040601</creationdate><title>Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: A prospective randomized clinical trial</title><author>Costa, Vital P ; Azuara-Blanco, Augusto ; Netland, Peter A ; Lesk, Mark R ; Arcieri, Enyr S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-e292t-56a08d138917e3ed3fd180b4bb84853d4bb8f84c5d5026afcb7048dbc2c41c4e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Antibiotics, Antineoplastic - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy, Adjuvant</topic><topic>Combined Modality Therapy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Glaucoma - drug therapy</topic><topic>Glaucoma - surgery</topic><topic>Glaucoma and intraocular pressure</topic><topic>Glaucoma Drainage Implants</topic><topic>Humans</topic><topic>Intraocular Pressure</topic><topic>Intraoperative Care</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mitomycin - therapeutic use</topic><topic>Ophthalmic Solutions</topic><topic>Ophthalmology</topic><topic>Prospective Studies</topic><topic>Prosthesis Implantation</topic><topic>Safety</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Surgery of the eye and orbit</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Costa, Vital P</creatorcontrib><creatorcontrib>Azuara-Blanco, Augusto</creatorcontrib><creatorcontrib>Netland, Peter A</creatorcontrib><creatorcontrib>Lesk, Mark R</creatorcontrib><creatorcontrib>Arcieri, Enyr S</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Costa, Vital P</au><au>Azuara-Blanco, Augusto</au><au>Netland, Peter A</au><au>Lesk, Mark R</au><au>Arcieri, Enyr S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: A prospective randomized clinical trial</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2004-06-01</date><risdate>2004</risdate><volume>111</volume><issue>6</issue><spage>1071</spage><epage>1076</epage><pages>1071-1076</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><coden>OPHTDG</coden><abstract>To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation.
Randomized controlled clinical trial.
Sixty patients with refractory glaucoma.
Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan–Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
After a mean follow-up of 12.3 months, Kaplan–Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan–Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (
P = 0.75 and
P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15177955</pmid><doi>10.1016/j.ophtha.2003.09.037</doi><tpages>6</tpages></addata></record> |
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| identifier | ISSN: 0161-6420 |
| ispartof | Ophthalmology (Rochester, Minn.), 2004-06, Vol.111 (6), p.1071-1076 |
| issn | 0161-6420 1549-4713 |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Antibiotics, Antineoplastic - therapeutic use Biological and medical sciences Chemotherapy, Adjuvant Combined Modality Therapy Female Follow-Up Studies Glaucoma - drug therapy Glaucoma - surgery Glaucoma and intraocular pressure Glaucoma Drainage Implants Humans Intraocular Pressure Intraoperative Care Male Medical sciences Middle Aged Mitomycin - therapeutic use Ophthalmic Solutions Ophthalmology Prospective Studies Prosthesis Implantation Safety Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the eye and orbit Survival Analysis Treatment Outcome |
| title | Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: A prospective randomized clinical trial |
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