Dataset Information

Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery.

ABSTRACT:

Introduction

To compare surgical outcomes of 2.2 mm clear corneal incision (CCI) between a three-dimensional (3D) visualization system and traditional binocular microscope (BM) for phacoemulsification and intraocular lens implantation surgery.

Methods

In this randomized controlled clinical study, 60 eyes with age-related cataracts were divided into two groups receiving cataract surgery using either a 3D vision system (n = 30 eyes) (3D group) or a binocular microscope (n = 30 eyes) (BM group). We recorded and statistically analyzed surgical parameters and pre- and postoperative ocular parameters. Primary outcomes included the change in endothelial cell density (ECD) and CCI architecture, and secondary outcomes comprised other ocular parameters and surgical parameters. All procedures complied with the tenets of the Declaration of Helsinki.

Results

Of the 60 eyes randomly assigned between January 5, 2021, and May 9, 2021, 55 (26 eyes in the 3D group and 29 eyes in the BM group) were analyzed. The ECD loss rate was 8.1% in the 3D group and 12.3% in the BM group, but the difference was not statistically significant. Local detachment of Descemet's membrane was seen in 50% (13 eyes, 3D group) and 51.6% (15 eyes, BM group), wound gaping at the endothelial side in 15.4% (four eyes, 3D group) and 10.3% (four eyes, BM group), gaping at the epithelial side in 11.5% (three eyes, 3D group) and 6.9% (two eyes, BM group), and misalignment of the incision in 3.4% (one eye, BM group) 1 day after surgery. These abnormalities improved with time. There was no difference between the 3D group and BM group in terms of other ocular parameters or surgical parameters before and after surgery.

Conclusions

Using the 3D surgical system for phacoemulsification and IOL implantation surgery seems to result in similar ECD and CCI conditions as using a conventional binocular microscope.

Trial registration

The protocol was registered on ClinicalTrials.gov (NCT04839250).

SUBMITTER: Zhu Z

PROVIDER: S-EPMC9244034 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceCataracts account for 40% of cases of blindness globally, with surgery the only treatment.ObjectiveTo determine whether adding simulation-based cataract surgical training to conventional training results in improved acquisition of surgical skills among trainees.Design, setting, and participantsA multicenter, investigator-masked, parallel-group, randomized clinical educational-intervention trial was conducted at 5 university hospital training institutions in Kenya, Tanzania, Uganda, and Zimbabwe from October 1, 2017, to September 30, 2019, with a follow-up of 15 months. Fifty-two trainee ophthalmologists were assessed for eligibility (required no prior cataract surgery as primary surgeon); 50 were recruited and randomized. Those assessing outcomes of surgical competency were masked to group assignment. Analysis was performed on an intention-to-treat basis.InterventionsThe intervention group received a 5-day simulation-based cataract surgical training course, in addition to standard surgical training. The control group received standard training only, without a placebo intervention; however, those in the control group received the intervention training after the initial 12-month follow-up period.Main outcomes and measuresThe primary outcome measure was overall surgical competency at 3 months, which was assessed with a validated competency assessment rubric. Secondary outcomes included surgical competence at 1 year and quantity and outcomes (including visual acuity and posterior capsule rupture) of cataract surgical procedures performed during a 1-year period.ResultsAmong the 50 participants (26 women [52.0%]; mean [SD] age, 32.3 [4.6] years), 25 were randomized to the intervention group, and 25 were randomized to the control group, with 1 dropout. Forty-nine participants were included in the final intention-to-treat analysis. Baseline characteristics were balanced. The participants in the intervention group had higher scores at 3 months compared with the participants in the control group, after adjusting for baseline assessment rubric score. The participants in the intervention group were estimated to have scores 16.6 points (out of 40) higher (95% CI, 14.4-18.7; P < .001) at 3 months than the participants in the control group. The participants in the intervention group performed a mean of 21.5 cataract surgical procedures in the year after the training, while the participants in the control group performed a mean of 8.5 cataract surgical procedures (mean difference, 13.0; 95% CI, 3.9-22.2; P < .001). Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001).Conclusions and relevanceThis randomized clinical trial provides evidence that intense simulation-based cataract surgical education facilitates the rapid acquisition of surgical competence and maximizes patient safety.Trial registrationPan-African Clinical Trial Registry, number PACTR201803002159198.