Dataset Information

A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).

ABSTRACT:

Objectives

To compare outcomes of femtosecond-enabled deep anterior lamellar keratoplasty (FE-DALK) and standard deep anterior lamellar keratoplasty (S-DALK).

Methods

An open label, randomized controlled trial (Kensington Eye Institute, Toronto, ON, Canada) including 100 eyes of 97 participants with either keratoconus or corneal scarring, randomized to either FE-DALK (n = 48) or S-DALK (n = 49).

Primary outcomes

postoperative astigmatism and surgically induced corneal astigmatism (SIA) - both at 15 months.

Secondary outcomes

6-, 12- and 15-month postoperative uncorrected- and best spectacle-corrected visual acuity, steep and flat keratometry, manifest sphere and astigmatism, rate of conversion to penetrating keratoplasty (PK), big-bubble success, central corneal thickness, endothelial cell count and complications.

Results

In intention-to-treat analysis, mean postoperative astigmatism in the FE-DALK (n = 30) and S-DALK (n = 30) groups at 15 months was 7.8 ± 4.4 D and 6.3 ± 5.0 D, respectively (p = 0.282) with an adjusted mean difference of 1.3 D (95% CI -1.08, +3.65). Mean SIA (arithmetic) was 9.2 ± 7.8 and 8.8 ± 5.4 D, respectively (p = 0.838) with a mean difference of 0.4 D (95% CI -3.13, +3.85). In an analysis of successful DALK cases only, mean postoperative astigmatism in the FE-DALK (n = 24) and S-DALK (n = 20) groups at 15 months (after excluding 4 eyes with AEs) was 7.3 ± 4.4 and 6.2 ± 4.9 D, respectively (p = 0.531) with an adjusted mean difference of 0.9 D (95% CI -1.94, +3.71). Mean SIA (arithmetic) was 9.1 ± 7.8 and 7.9 ± 4.6 D, respectively (p = 0.547) with a mean difference of 1.2 D (95% CI -2.70,+5.02). Comparison of secondary outcomes showed only weak statistical evidence.

Conclusions

In this randomized controlled trial, FE-DALK and S-DALK showed comparable functional and anatomical outcomes.

SUBMITTER: Sorkin N

PROVIDER: S-EPMC10482827 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).

Sorkin Nir N Hatch Wendy W Mimouni Michael M Chew Hall F HF Rootman David S DS Slomovic Allan R AR Bujak Matthew C MC Chan Clara C CC Thorpe Kevin E KE Perez Mauricio M Stiuso Vera V Singal Neera N

Eye (London, England) 20230124 13

<h4>Objectives</h4>To compare outcomes of femtosecond-enabled deep anterior lamellar keratoplasty (FE-DALK) and standard deep anterior lamellar keratoplasty (S-DALK).<h4>Methods</h4>An open label, randomized controlled trial (Kensington Eye Institute, Toronto, ON, Canada) including 100 eyes of 97 participants with either keratoconus or corneal scarring, randomized to either FE-DALK (n = 48) or S-DALK (n = 49).<h4>Primary outcomes</h4>postoperative astigmatism and surgically induced corneal astig ...[more]

PMID: 36693916

Similar Datasets

Project description:PurposeTo evaluate difference in therapeutic outcomes between deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PKP) for the clinical treatment of keratoconus.MethodsA comprehensive search was conducted in Pubmed, EMBASE, Cochrane Library, and Web of science. Eligible studies should include at least one of the following factors: best corrected visual acuity (BCVA), postoperative spherical equivalent (SE), postoperative astigmatism and endothelial cell count (ECC), central corneal thickness (CCT), graft rejection and graft failure, of which BCVA, graft rejection and graft failure were used as the primary outcome measures, and postoperative SE, astigmatism, CCT and ECC as the secondary outcome measures. Given the lack of randomized clinical trials (RCTs), cohort studies and prospective studies were considered eligible.ResultsSixteen clinical trials involving 6625 eyes were included in this review, including 1185 eyes in DALK group, and 5440 eyes in PKP group. The outcomes were analyzed using Cochrane Review Manager (RevMan) version 5.0 software. The postoperative BCVA in DALK group was significantly better than that in PKP group (OR = 0.48; 95%CI 0.39 to 0.60; p<0.001). There were fewer cases of graft rejection in DALK group than those in PKP group (OR = 0.28; 95%CI 0.15 to 0.50; p<0.001). Nevertheless the rate of graft failure was similar between DALK and PKP groups (OR = 1.05; 95%CI 0.81 to 1.36; p = 0.73). There were no significant differences in the secondary outcomes of SE (p = 0.70), astigmatism (p = 0.14) and CCT (p = 0.58) between DALK and PKP groups. And ECC in DALK group was significantly higher than PKP group (p<0.001). The postoperative complications, high intraocular pressure (high-IOP) and cataract were analyzed, fewer cases of complications occurred in DALK group than those in PKP group (high-IOP, OR 0.22, 95% CI 0.11-0.44, P<0.001) (cataract, OR 0.22; 95% CI 0.08-0.61, P = 0.004). And no cases of expulsive hemorrhage and endophthalmitis were reported.ConclusionThe visual outcomes for DALK were not equivalent to PKP. The rate of graft failure was similar between DALK and PKP. Fewer postoperative complications occurred in DALK group, indicating that compared with PKP, DALK has lower efficacy but higher safety.

Project description:PurposeTo theoretically compare corneal displacement and the von Mises (VM) stress distribution of deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PK) for keratoconus (KC) and to evaluate the effects of residual stromal thickness (RST) and intraocular pressure (IOP) on postoperative corneal biomechanics.MethodsWe performed DALK and PK simulations using Ansys by employing anisotropic nonlinear hyperelastic corneal material properties. We analyzed corneal displacement and VM stress in DALK and PK models under IOPs of 10, 15, 20, and 25 mmHg. We established two DALK models: The ideal-type DALK ensured that postoperative central corneal thickness was constant at 560 µm and the corneal graft thickness varied with RST. The clinical-type DALK ensured that corneal grafts had the same thickness (500 µm) regardless of RST. Then we analyzed the effects of RST and IOP on postoperative corneal displacement and VM stress.ResultsCorneal displacement and VM stress were lower in the DALK than in the PK model. In the ideal-type DALK model, an increase in RST was associated with increased deformation and decreased VM stress in the healing zone, except for a RST of 0 µm. In the clinical-type DALK model, deformation and VM stress in the healing zone decreased with an increase in RST, except for a RST of 0 µm.ConclusionsDALK showed more stability than PK. For the ideal-type DALK model, an increase in RST resulted in decreased postoperative corneal biomechanics in the healing zone. For the clinical-type DALK model, corneal deformation and VM stress decreased with an increase in RST, which provides numerical evidence for the design of corneal transplantation for patients with KC.Translational relevanceIn this computational modeling study, we first theoretically compared corneal biomechanics between DALK and PK for KC. Then, the effects of RST and IOP on postoperative corneal biomechanics were investigated. Our findings provide novel insights into the optimal design for corneal transplantation for patients with KC.

Dataset Information

A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).

Objectives

Methods

Primary outcomes

Secondary outcomes

Results

Conclusions

Publications

A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).

Similar Datasets

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