Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty
ObjectiveTo evaluate if an intraoperative-OCT (iOCT) optimized surgical protocol without prolonged overpressure is non-inferior to a standard protocol during Descemet membrane endothelial keratoplasty (DMEK).MethodsSixty-five pseudophakic eyes of 65 patients with Fuchs endothelial dystrophy schedule...
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Frontiers Media S.A.
2023-01-01
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| Series: | Frontiers in Ophthalmology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fopht.2022.1041778/full |
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| author | Marc B. Muijzer Heleen Delbeke Heleen Delbeke Mor M. Dickman Rudy M.M.A. Nuijts Herke Jan Noordmans Saskia M. Imhof Robert P. L. Wisse |
| author_facet | Marc B. Muijzer Heleen Delbeke Heleen Delbeke Mor M. Dickman Rudy M.M.A. Nuijts Herke Jan Noordmans Saskia M. Imhof Robert P. L. Wisse |
| author_sort | Marc B. Muijzer |
| collection | DOAJ |
| description | ObjectiveTo evaluate if an intraoperative-OCT (iOCT) optimized surgical protocol without prolonged overpressure is non-inferior to a standard protocol during Descemet membrane endothelial keratoplasty (DMEK).MethodsSixty-five pseudophakic eyes of 65 patients with Fuchs endothelial dystrophy scheduled for routine DMEK were recruited in this prospective non-inferiority international multicenter randomized control trial. Subjects were randomized to the control arm (n=33) without iOCT-use and raising the intraocular pressure above normal physiological limits for 8 minutes (i.e., overpressure) or the intervention arm (n=32) with OCT-guidance to assess graft orientation and adherence, while refraining from prolonged overpressure. The primary outcome was the incidence of postoperative surgery-related adverse events (AE). The non-inferiority margin was set at a risk difference of 10%. Secondary outcomes included iOCT-aided surgical decision making, surgical times, and endothelial cell density (ECD) corrected distance visual acuity (CDVA) at 6 months follow-up.ResultsIn the intervention group, 12 subjects developed 13 AEs compared to 13 AEs in 10 subjects in the control group (P=0.644). The risk difference measured -0.32% (95%CI: -10.29 – 9.84). The ECD and CDVA did not differ between the two groups 3 and 6 months postoperatively (P=>0.05). Surgeons reported that iOCT aided surgical decision-making in 40% of cases. Surgery and graft unfolding time were, respectively, 13% and 27% shorter in the iOCT-group.ConclusionsiOCT-guided DMEK surgery with refraining from prolonged over-pressuring was non-inferior compared to conventional treatment. Surgery times were reduced considerably and iOCT aided surgical decision-making in 40% of cases. Refraining from prolonged overpressure did not affect postoperative ECD or CDVA.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03763721 (NCT03763721). |
| first_indexed | 2024-04-10T23:29:41Z |
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| id | doaj.art-3e300d5e4b564784b3fd0ff3651fa114 |
| institution | Directory Open Access Journal |
| issn | 2674-0826 |
| language | English |
| last_indexed | 2024-04-10T23:29:41Z |
| publishDate | 2023-01-01 |
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| series | Frontiers in Ophthalmology |
| spelling | doaj.art-3e300d5e4b564784b3fd0ff3651fa1142023-01-12T07:21:40ZengFrontiers Media S.A.Frontiers in Ophthalmology2674-08262023-01-01210.3389/fopht.2022.10417781041778Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplastyMarc B. Muijzer0Heleen Delbeke1Heleen Delbeke2Mor M. Dickman3Rudy M.M.A. Nuijts4Herke Jan Noordmans5Saskia M. Imhof6Robert P. L. Wisse7Utrecht Cornea Research Group, Ophthalmology Department, University Medical Center Utrecht, Utrecht, NetherlandsOphthalmology Department, University Hospital Leuven, Leuven, BelgiumKatholieke Universiteit (KU) Leuven, Biomedical Sciences Group, Department of Neurosciences, Research group Ophthalmology, Leuven, BelgiumUniversity Eye Clinic, Maastricht University Medical Center, Maastricht, NetherlandsUniversity Eye Clinic, Maastricht University Medical Center, Maastricht, NetherlandsMedical Technical and Clinical Physics Department, University Medical Center Utrecht, Utrecht, NetherlandsUtrecht Cornea Research Group, Ophthalmology Department, University Medical Center Utrecht, Utrecht, NetherlandsUtrecht Cornea Research Group, Ophthalmology Department, University Medical Center Utrecht, Utrecht, NetherlandsObjectiveTo evaluate if an intraoperative-OCT (iOCT) optimized surgical protocol without prolonged overpressure is non-inferior to a standard protocol during Descemet membrane endothelial keratoplasty (DMEK).MethodsSixty-five pseudophakic eyes of 65 patients with Fuchs endothelial dystrophy scheduled for routine DMEK were recruited in this prospective non-inferiority international multicenter randomized control trial. Subjects were randomized to the control arm (n=33) without iOCT-use and raising the intraocular pressure above normal physiological limits for 8 minutes (i.e., overpressure) or the intervention arm (n=32) with OCT-guidance to assess graft orientation and adherence, while refraining from prolonged overpressure. The primary outcome was the incidence of postoperative surgery-related adverse events (AE). The non-inferiority margin was set at a risk difference of 10%. Secondary outcomes included iOCT-aided surgical decision making, surgical times, and endothelial cell density (ECD) corrected distance visual acuity (CDVA) at 6 months follow-up.ResultsIn the intervention group, 12 subjects developed 13 AEs compared to 13 AEs in 10 subjects in the control group (P=0.644). The risk difference measured -0.32% (95%CI: -10.29 – 9.84). The ECD and CDVA did not differ between the two groups 3 and 6 months postoperatively (P=>0.05). Surgeons reported that iOCT aided surgical decision-making in 40% of cases. Surgery and graft unfolding time were, respectively, 13% and 27% shorter in the iOCT-group.ConclusionsiOCT-guided DMEK surgery with refraining from prolonged over-pressuring was non-inferior compared to conventional treatment. Surgery times were reduced considerably and iOCT aided surgical decision-making in 40% of cases. Refraining from prolonged overpressure did not affect postoperative ECD or CDVA.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03763721 (NCT03763721).https://www.frontiersin.org/articles/10.3389/fopht.2022.1041778/fullintraoperative OCTiOCTDescemet membrane endothelial keratoplastyDMEKcorneal imaging |
| spellingShingle | Marc B. Muijzer Heleen Delbeke Heleen Delbeke Mor M. Dickman Rudy M.M.A. Nuijts Herke Jan Noordmans Saskia M. Imhof Robert P. L. Wisse Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty Frontiers in Ophthalmology intraoperative OCT iOCT Descemet membrane endothelial keratoplasty DMEK corneal imaging |
| title | Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty |
| title_full | Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty |
| title_fullStr | Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty |
| title_full_unstemmed | Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty |
| title_short | Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty |
| title_sort | outcomes of the advanced visualization in corneal surgery evaluation trial a non inferiority randomized control trial to evaluate the use of intraoperative oct during descemet membrane endothelial keratoplasty |
| topic | intraoperative OCT iOCT Descemet membrane endothelial keratoplasty DMEK corneal imaging |
| url | https://www.frontiersin.org/articles/10.3389/fopht.2022.1041778/full |
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