Dataset Information

Intense Simulation-Based Surgical Education for Manual Small-Incision Cataract Surgery: The Ophthalmic Learning and Improvement Initiative in Cataract Surgery Randomized Clinical Trial in Kenya, Tanzania, Uganda, and Zimbabwe.

ABSTRACT:

Importance

Cataracts account for 40% of cases of blindness globally, with surgery the only treatment.

Objective

To determine whether adding simulation-based cataract surgical training to conventional training results in improved acquisition of surgical skills among trainees.

Design, setting, and participants

A 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.

Interventions

The 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 measures

The 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.

Results

Among 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 relevance

This randomized clinical trial provides evidence that intense simulation-based cataract surgical education facilitates the rapid acquisition of surgical competence and maximizes patient safety.

Trial registration

Pan-African Clinical Trial Registry, number PACTR201803002159198.

SUBMITTER: Dean WH

PROVIDER: S-EPMC7645744 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceIncision-related Descemet membrane detachment (DMD) is a common complication of cataract surgery. Most postoperative severe DMD that leads to corneal decompensation originates from intraoperative incision-related DMD. It is important to determine the incidence, extent, and associated risk factors of intraoperative DMD at each step of surgery to help in formulating precise and effective prevention strategies.ObjectivesTo investigate the intraoperative development of incision-site DMD associated with a 2.2-mm clear corneal incision during cataract surgery and to analyze its associated factors.Design, setting, and participantsIn this case series, consecutive, prospectively enrolled 133 patients with cataract 50 to 90 years of age (133 eyes) undergoing coaxial 2.2-mm clear corneal microincision phacoemulsification with intraocular lens (IOL) implantation between January 1 and March 31, 2019, at Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China, were studied.ExposuresCoaxial 2.2-mm clear corneal microincision phacoemulsification with IOL implantation.Main outcomes and measuresReal-time incidence and extent of intraoperative incision-related DMD at each step of surgery.ResultsAmong 133 patients with cataracts (mean [SD] age, 72.3 [8.1] years; 77 [57.9%] female), DMD was encountered in 125 eyes (94.0%), occurring at the following steps: capsulorrhexis (2 [1.6%]), hydrodissection (7 [5.6%]), phacoemulsification (69 [55.2%]), irrigation-aspiration (44 [35.2%]), and IOL implantation (3 [2.4%]). The extent of DMD increased during the operation (mean [SD] difference between final and initial relative DMD length, 22.8% [1.4%]; 95% CI, 20.0-25.6; P < .001). Associations for the extent of DMD found in multivariate stepwise analyses included time of ultrasonography (β = 0.34; 95% CI, 0.17-0.50; P < .001), equivalent mean ultrasonic power (β = 87.8; 95% CI, 19.1-156.4; P = .01), and the presence of DMD at the anterior and posterior wound margins (coefficient = 16.7; 95% CI, 6.4-26.9; P = .002).Conclusions and relevanceThe results of this case series suggest that friction of surgical instruments has the greatest association with incisional DMD. Decreasing ultrasonic energy and phacoemulsification time may reduce the severity of incisional DMD.

Project description:BackgroundAccumulating evidence suggests that refractive stabilization occurs rapidly following small incision cataract surgery. Nonetheless, many guidelines still suggest waiting four to 6 weeks before prescribing corrective lenses. This study was undertaken to supplement the existing literature regarding refractive stabilization, and evaluate multiple contributing factors that could dissuade clinicians from confidently correcting refractive error in the early post-operative course following routine cataract surgeries.MethodsAdult patients undergoing phacoemulsification cataract surgery with uncomplicated surgeries and post-surgical courses at the Calgary Ophthalmology Centre (Calgary, Alberta, Canada) were included in this prospective observational case series. Exclusion criteria included known corneal dystrophies, infectious keratitis, complicated surgery or toric/multifocal IOLs. Data was collected at weekly intervals for a total of 6 weeks. Collected data included autorefraction, visual acuity, corneal pachymetry, and effective lens position.ResultsOne hundred six eyes of 104 patients were included in this study. Post-operative sphere, cylinder and spherical equivalent were not significantly different at any post-operative week compared with week six, and 80-86% of patients were within 0.5D of last follow-up spherical equivalent at any week. The secondary outcomes of central corneal thickness, effective lens position and visual acuity did, however, exhibit significant differences between early post-operative weeks and last follow-up values.ConclusionsThese data suggest that refractive error can be effectively measured and corrected as early as one-week post-operatively in the majority of patients, though other measures of post-operative stability including central corneal thickness, effective lens position and visual acuity can require up to 4 weeks to stabilize. Thus a conservative and pragmatic approach may be to wait until 4 weeks post-operatively prior to obtaining refractive correction following uncomplicated phacoemulsification cataract surgery.