China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial

NCT03458442 | Completed

• 1 other identifier: China OLIMPICS* Trial
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, investigator-masked randomised controlled education-intervention trial of intense simulation-based surgical education plus conventional training versus a current six-week standard training course. The aim is to investigate whether the addition of simulation-based surgical education to standard training improves competence and surgical outcomes. All participants in the study will receive the educational intervention of the six-week Orbis-COS course. The intervention groups will receive this training and an additional element of learning and sustained deliberate practice using model eyes and simulation.

Conditions

Cataract

Keywords

education; developing country; developing countries; low-and middle-income country; low-and middle-income countries; surgical training; blindness; china; simulation; model

Outcome Measures

Primary Outcomes (1)

• Surgical Skill - ICO OSCAR Score

  Mean video grade of first 10 successive supervised or assisted SICS cases (with patient consent) for each trainee surgeon, using ICO-OSCAR. Two approaches to determine mean video grade will be employed to account for variation in the number of surgical steps performed by trainees. Both approaches are equally significant for determining main outcome, differing solely in number of steps graded. * Mean video grade across all surgical steps of first 10 supervised SICS cases for each trainee, using ICO-OSCAR. This approach assigns a score 0 for steps not performed. * Mean video grade across all trainee-completed steps of first 10 supervised SICS cases for each trainee, using ICO-OSCAR. This approach takes into consideration mentors' teaching styles. The graders are masked to surgeon/patient identity, using a file-sharing platform to transfer videos to graders and collate grading information. These are the first 10/30 cases completed under STEER trainer supervision.

  First 10 successive independent surgeries after training--expected within 6 months after completion of training

Secondary Outcomes (3)

• Post-operative Presenting Visual Acuity

  Post-operative day #1

• Post-operative Improvement in Visual Acuity

  Post-operative day #1

• Cost per trainee

  After conclusion of study activity--calculated up to 1 month after data from final surgery collected

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Standard surgical training + simulation-based surgical training

Other: Simulation-based surgical training; Other: Standard surgical training

Control Arm

ACTIVE COMPARATOR

Standard surgical training

Other: Standard surgical training

Interventions

Simulation-based surgical training OTHER

Those in the intervention group will be introduced to a variety of simulation-based surgical training techniques. Specifically, this will involve breaking down the SICS cataract surgery procedure into stages, and practicing each stage repeatedly using simulation. This sustained deliberate practice will be integrated into the six-week course, as an enhancement to the course, and not as a replacement of any part of the educational content. Within the last three weeks of the course, 'intervention' arm participants will be introduced to the artificial eyes, the Simulation-OSSCAR rubric, and be provided with ongoing feedback. All participants in both intervention and control arms will undertake the six-week Orbis-COS training course.

Intervention Arm

Standard surgical training OTHER

Standard surgical training (without bespoke training scheme using simulation and model eye). All participants in both intervention and control arms will undertake the existing six-week Orbis-COS training course, which includes 2-4 weeks of didactic lectures, surgical observation, and wet lab training with a minimum of 50 pig eye wet lab simulations per trainee. After observed mastery of wet lab pig eyes, trainees then perform hands-on training in county level hospitals. The hands-on training pairs a surgeon from the training centre to mentor the trainee through a minimum of 30 assisted surgeries and 50 independent surgeries under supervision.

Control Arm; Intervention Arm

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \<20 complete SICS cases performed lifetime
• Completed ophthalmic training or in residency training with license to perform surgery
• Will have opportunity to carry out independent SICS surgery after training
• Patient Enrolment Criteria:
• Cataract in one or both eyes felt to be visually significant in the opinion of the operating ophthalmologist.

You may not qualify if:

• Already capable of performing independent intra-ocular surgery of any kind
• No opportunity to perform cataract surgery after training.
• Fellow eye has an irreversible cause of visual impairment
• Any prior ophthalmic surgery in the proposed operative eye

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (4)

• Murthy G, Gupta SK, John N, Vashist P. Current status of cataract blindness and Vision 2020: the right to sight initiative in India. Indian J Ophthalmol. 2008 Nov-Dec;56(6):489-94. doi: 10.4103/0301-4738.42774.

  PMID: 18974520 BACKGROUND

• Young AL, Jhanji V, Liang Y, Congdon N, Chow S, Wang F, Zhang X, Man X, Yang M, Lin Z, Yuen HG, Lam DS. A survey of perceived training differences between ophthalmology residents in Hong Kong and China. BMC Med Educ. 2015 Sep 28;15:158. doi: 10.1186/s12909-015-0440-0.

  PMID: 26415932 BACKGROUND

• Resnikoff S, Felch W, Gauthier TM, Spivey B. The number of ophthalmologists in practice and training worldwide: a growing gap despite more than 200,000 practitioners. Br J Ophthalmol. 2012 Jun;96(6):783-7. doi: 10.1136/bjophthalmol-2011-301378. Epub 2012 Mar 26.

  PMID: 22452836 BACKGROUND

• Golnik C, Beaver H, Gauba V, Lee AG, Mayorga E, Palis G, Saleh GM. Development of a new valid, reliable, and internationally applicable assessment tool of residents' competence in ophthalmic surgery (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2013 Sep;111:24-33.

  PMID: 24072944 BACKGROUND

MeSH Terms

Conditions

Cataract; Blindness

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan Congdon, MD, MPH

  Zongshan Ophthalmic Center

  PRINCIPAL INVESTIGATOR

• William Dean, FRCO MBChB

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Ningli Wang

  Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventative Ophthalmology

Study Record Dates

• First Submitted: October 7, 2017
• First Posted: March 8, 2018
• Study Start: May 9, 2018
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 19, 2021

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)