Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial
To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). Multicenter, randomized controlled trial funded by the UK National Institute...
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| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 2020-08, Vol.127 (8), p.1012-1019 |
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| creator | Day, Alexander C Burr, Jennifer M Bennett, Kate Bunce, Catey Doré, Caroline J Rubin, Gary S Nanavaty, Mayank A Balaggan, Kamaljit S Wilkins, Mark R |
| description | To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).
Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).
Seven hundred eighty-five patients with age-related cataract.
This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.
We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.
Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited. |
| doi_str_mv | 10.1016/j.ophtha.2020.02.028 |
| format | Article |
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Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).
Seven hundred eighty-five patients with age-related cataract.
This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.
We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.
Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2020.02.028</identifier><identifier>PMID: 32386810</identifier><language>eng</language><publisher>United States: Elsevier</publisher><subject>Aged ; Cost-Benefit Analysis ; Female ; Follow-Up Studies ; Humans ; Laser Therapy - methods ; Male ; Phacoemulsification - economics ; Phacoemulsification - methods ; Retrospective Studies ; Treatment Outcome ; Visual Acuity</subject><ispartof>Ophthalmology (Rochester, Minn.), 2020-08, Vol.127 (8), p.1012-1019</ispartof><rights>Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.</rights><rights>2020 by the American Academy of OphthalmologyThis is an open access article under the CC BY license (<inter-ref xlink: href=http://creativecommons.org/licenses/by/4.0/>http://creativecommons.org/licenses/by/4.0/</inter-ref>). 2020 American Academy of Ophthalmology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32386810$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Day, Alexander C</creatorcontrib><creatorcontrib>Burr, Jennifer M</creatorcontrib><creatorcontrib>Bennett, Kate</creatorcontrib><creatorcontrib>Bunce, Catey</creatorcontrib><creatorcontrib>Doré, Caroline J</creatorcontrib><creatorcontrib>Rubin, Gary S</creatorcontrib><creatorcontrib>Nanavaty, Mayank A</creatorcontrib><creatorcontrib>Balaggan, Kamaljit S</creatorcontrib><creatorcontrib>Wilkins, Mark R</creatorcontrib><creatorcontrib>FACT group</creatorcontrib><title>Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).
Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).
Seven hundred eighty-five patients with age-related cataract.
This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.
We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.
Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.</description><subject>Aged</subject><subject>Cost-Benefit Analysis</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Laser Therapy - methods</subject><subject>Male</subject><subject>Phacoemulsification - economics</subject><subject>Phacoemulsification - methods</subject><subject>Retrospective Studies</subject><subject>Treatment Outcome</subject><subject>Visual Acuity</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplkM9LwzAcxYMoOqf_gUiPeujMryaNB2EMp8JQ0em1xPRbF2mbmaTCvPmfW3CKIjx4h_f4PHgIHRA8IpiIk5eRWy7iQo8opniEaa98Aw1IxlXKJWGbaNDXSCo4xTtoN4QXjLEQjG-jHUZZLnKCB-hjCk10AYxry2SmA_h0HIINEcpkoqP22sTkvvPP4FfJI_jQheR2oY2DpquDrazR0br2f_doOp7Mj0-TcXKn29I19r0nXrvWthV467yNq2Tura730Fal6wD7ax-ih-n5fHKZzm4uribjWbqkQsTUlMBKCURomikJvOJCZpVSBqrMKEIYz4A8KSlyQ7FUQnJRGZPnwhjOcsLZEJ19cZfdUwOlgTZ6XRdLbxvtV4XTtvibtHZRPLu3QjIluVI94GgN8O61gxCLxgYDda1bcF0oKMeEkCzrPx6iw99bPyPfv7NPlbOJlQ</recordid><startdate>202008</startdate><enddate>202008</enddate><creator>Day, Alexander C</creator><creator>Burr, Jennifer M</creator><creator>Bennett, Kate</creator><creator>Bunce, Catey</creator><creator>Doré, Caroline J</creator><creator>Rubin, Gary S</creator><creator>Nanavaty, Mayank A</creator><creator>Balaggan, Kamaljit S</creator><creator>Wilkins, Mark R</creator><general>Elsevier</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>202008</creationdate><title>Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial</title><author>Day, Alexander C ; Burr, Jennifer M ; Bennett, Kate ; Bunce, Catey ; Doré, Caroline J ; Rubin, Gary S ; Nanavaty, Mayank A ; Balaggan, Kamaljit S ; Wilkins, Mark R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p266t-cde3d7e16a2597e4f4675f99cef5c911345e1b9768c20796746fcc886cc438143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Cost-Benefit Analysis</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Laser Therapy - methods</topic><topic>Male</topic><topic>Phacoemulsification - economics</topic><topic>Phacoemulsification - methods</topic><topic>Retrospective Studies</topic><topic>Treatment Outcome</topic><topic>Visual Acuity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Day, Alexander C</creatorcontrib><creatorcontrib>Burr, Jennifer M</creatorcontrib><creatorcontrib>Bennett, Kate</creatorcontrib><creatorcontrib>Bunce, Catey</creatorcontrib><creatorcontrib>Doré, Caroline J</creatorcontrib><creatorcontrib>Rubin, Gary S</creatorcontrib><creatorcontrib>Nanavaty, Mayank A</creatorcontrib><creatorcontrib>Balaggan, Kamaljit S</creatorcontrib><creatorcontrib>Wilkins, Mark R</creatorcontrib><creatorcontrib>FACT group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Day, Alexander C</au><au>Burr, Jennifer M</au><au>Bennett, Kate</au><au>Bunce, Catey</au><au>Doré, Caroline J</au><au>Rubin, Gary S</au><au>Nanavaty, Mayank A</au><au>Balaggan, Kamaljit S</au><au>Wilkins, Mark R</au><aucorp>FACT group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2020-08</date><risdate>2020</risdate><volume>127</volume><issue>8</issue><spage>1012</spage><epage>1019</epage><pages>1012-1019</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><abstract>To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).
Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).
Seven hundred eighty-five patients with age-related cataract.
This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.
We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.
Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.</abstract><cop>United States</cop><pub>Elsevier</pub><pmid>32386810</pmid><doi>10.1016/j.ophtha.2020.02.028</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Ophthalmology (Rochester, Minn.), 2020-08, Vol.127 (8), p.1012-1019 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Aged Cost-Benefit Analysis Female Follow-Up Studies Humans Laser Therapy - methods Male Phacoemulsification - economics Phacoemulsification - methods Retrospective Studies Treatment Outcome Visual Acuity |
| title | Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial |
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