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

• ClinicalTrials.gov Identifier: NCT03458442
• Recruitment Status: Completed
• First Posted: March 8, 2018
• Last Update Posted: March 19, 2021
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Congdon Nathan, Sun Yat-sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cataract	Other: Simulation-based surgical training; Other: Standard surgical training	Not Applicable

Detailed Description:

Project Description:

The leading cause of blindness in China and the world is un-operated cataract. Despite notable efforts on the part of the Chinese government, China's cataract surgical rate (1400/million/year in 2015) remains behind that of many of its poorer neighbours, such as India (6500) and Vietnam (2250). An important reason is the unavailability of trained surgeons: though China has over 36,000 ophthalmologists, only a third are capable of performing independent cataract surgery. This shortfall is due in large part to lack of hands-on training opportunities. A recent survey of residents at China's top-ranked resident training programs found that the median number of independent cataract surgeries performed was actually zero. The problem persists after formal training is completed: <5% of cataract surgeries are performed by doctors aged 24-43 years. The problem is particularly acute in rural areas, where hands-on training opportunities for young ophthalmic surgeons are even rarer. One reason is safety concerns on the part of patients and senior doctors in entrusting operations to young surgeons.

New training models for cataract surgery are needed which can safely and efficiently support trainees during the transition from novice to competent surgeon. Simulation-based surgical training, using high-fidelity, inexpensive, re-usable model eyes have been successfully piloted. The investigators now propose to carry out a randomized trial comparing training using these model eyes with traditional techniques, to study the impact on quality of surgery (assessed by masked grading of videos using the ICO OSCAR system), visual acuity and cost-utility outcomes.

The investigators research will reduce expenses by piggybacking on an on-going collaborative program between Orbis International, the Chinese MOH, Chinese National Blindness Prevention Committee and Tongren Hosptal (one of China's largest and best-respected eye hospitals), which will train 120 rural cataract surgeons at 60 county hospitals in 6 provinces. The study's collaboration involves internationally-respected vision research teams at ICEH, Queen's University Belfast and Tongren, while offering opportunities for scale-up and engagement with Chinese policy makers at the highest level.

A successful trial proving the training benefits of inexpensive model eyes will make a unique contribution to building the capacity to manage China's leading cause of blindness, thus furthering the aims of SightFirst and the Chinese Ministry of Health, while improving the lives of Chinese people dwelling in low-resource areas.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study
• Actual Study Start Date: May 9, 2018
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: February 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Arm; Standard surgical training + simulation-based surgical training	Other: Simulation-based surgical training; 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.; Other: Standard surgical training; 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.
Active Comparator: Control Arm; Standard surgical training	Other: Standard surgical training; 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.

Outcome Measures

Primary Outcome Measures :

1. Surgical Skill - ICO OSCAR Score [ Time Frame: First 10 successive independent surgeries after training--expected within 6 months after completion of training ]

   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.

Secondary Outcome Measures :

1. Post-operative Presenting Visual Acuity [ Time Frame: Post-operative day #1 ]
   Mean presenting logMAR visual acuity, on post-operative day #1 of 10 successive cases per surgeon (measured using the BOOST [Better Operative Outcome Software Tool] application.
2. Post-operative Improvement in Visual Acuity [ Time Frame: Post-operative day #1 ]
   Mean improvement in lines of visual acuity, on post-operative day #1 of 10 successive cases per surgeon (measured using the BOOST [Better Operative Outcome Software Tool] application.
3. Cost per trainee [ Time Frame: After conclusion of study activity--calculated up to 1 month after data from final surgery collected ]
   Cost per trainee in each wing

Eligibility Criteria

• Ages Eligible for Study: 0 Years to 100 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Surgeon Inclusion Criteria:

  • <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.

Exclusion Criteria:

• Surgeon Exclusion Criteria:

  • Already capable of performing independent intra-ocular surgery of any kind
  • No opportunity to perform cataract surgery after training.

• Patient Exclusion Criteria:

  • Fellow eye has an irreversible cause of visual impairment
  • Any prior ophthalmic surgery in the proposed operative eye
  • Any co-morbid condition in the operative eye likely to impact post-operative visual acuity negatively (conditions only detected on post-operative examination would also lead to retrospective exclusion.)

Contacts and Locations

Locations

China, Guangdong

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China, 510000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

• Principal Investigator: 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

  Study Documents (Full-Text)

Documents provided by Congdon Nathan, Sun Yat-sen University:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] October 9, 2018

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Congdon Nathan, Professor of Preventative Ophthalmology, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03458442
• Other Study ID Numbers: China OLIMPICS* Trial
• First Posted: March 8, 2018
• Last Update Posted: March 19, 2021
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Congdon Nathan, Sun Yat-sen University:

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

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases