Clinical trial NCT03458442: China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial
Official title: China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: education
developing country
developing countries
low-and middle-income country
low-and middle-income countries
surgical training
blindness
china
simulation
model
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 32
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.)

Primary outcomes:
measure: Surgical Skill - ICO OSCAR Score
timeFrame: First 10 successive independent surgeries after training--expected within 6 months after completion of training
Secondary outcomes:
measure: Post-operative Presenting Visual Acuity
timeFrame: Post-operative day #1
measure: Post-operative Improvement in Visual Acuity
timeFrame: Post-operative day #1
measure: Cost per trainee
timeFrame: After conclusion of study activity--calculated up to 1 month after data from final surgery collected
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zongshan Ophthalmic Center
name: Nathan Congdon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: William Dean, FRCO MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongren Hospital
name: Ningli Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.