MicrosurgeryNCT04093063
Validating an Inexpensive Practice Model for Microsurgical Skills Training
A study testing Micro-stellated Icosahedron in people with Microsurgery, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
A single-center, prospective, randomized, controlled intervention trial to validate an inexpensive practice model for acquisition of microsurgical skills. Following a pre-assessment microsurgical skills task, participants were randomized to either an intervention group to build a micro-stellated icosahedron, or to a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microsurgery
- What is being tested?
- Micro-stellated Icosahedron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 23 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year-old or older.
- No prior microsurgical experience.
Who cannot join
- Prior microsurgical experience.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacobs School of Medicine and Biomedical Sciences
Buffalo, New York, 14203
About this study
Official title: An Inexpensive Practice Model for Microsurgical Skills Training: A Randomized Trial
A single-center, prospective, randomized, controlled intervention trial to validate an inexpensive practice model for acquisition of microsurgical skills. Following a pre-assessment microsurgical skills task, participants were randomized to either an intervention group to build a micro-stellated icosahedron, or to a control group with no specific task assigned. A post-assessment microsurgical skills task was given to all participants after two weeks. Videos of pre- and post-assessments were masked and independently rated by two ophthalmologists using Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) scoring criteria. Analyses were done to determine improvement in time required to complete tasks and in scores between pre- and post- assessments.
Read the detailed description
This study is a single-center, prospective, randomized trial approved by the University at Buffalo Institutional Review Board. Medical students, residents and other interested individuals without prior microsurgery experience affiliated with the Jacobs School of Medicine and Biomedical Sciences were invited to participate. Each participant completed written informed consent.
Participants first watched an instructional video made by the Principal Investigator on how to pass a 9-0 nylon suture needle, and how to perform a microsurgical tie for a linear incision in a silicon baking mat using the same materials as would be provided to them for the pre- and post-assessments (Video 1). After watching the video three consecutive times, participants were tasked to pass and tie a 9-0 nylon suture in the same manner as the video recording. Their attempt at performing the microsurgical task was video-recorded for a pre-assessment with a cellphone camera focusing on the microscope field ensuring a clear view of the surgical field and the participant's instrument manipulation. Each subject wore gloves during the assessment to ensure anonymity.
After completion of the video-recorded pre-assessment, participants were randomized by flip of a coin to either the intervention group to build a micro-stellated icosahedron, or to the non-intervention control group with no assigned task. All subjects in both groups were required to return in two weeks for a second in-person meeting. At the second meeting, they were presented with the same instructional video as in the first meeting on how to pass a needle and perform a microsurgical tie. After watching the video three consecutive times, their attempt at completing a microsurgical tie was video-recorded for a post-assessment, using similar instruments and set-up as those used two weeks prior. Subjects in the intervention group were asked to return borrowed materials and their completed micro-stellated icosahedrons.
After all subjects were recruited, and their corresponding microsurgical tasks were video-recorded for pre- and post-assessments, each of the videos was edited to mute all audio in order to ensure anonymity. Each of the videos was de-identified by naming it with a random number from 1 to 42 and saved in a file folder in random order. This file folder was sent separately to two ophthalmologists, masked to the identity of the subjects (intervention vs control) and time of recording (pre- or post-assessment).
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which scores four criteria with scores from 1 to 5: Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique.4 The raters assigned separate scores for the participant's attempt at passing the needle through the incision, and for their attempt at tying a microsurgical tie. The attempt at passing the needle (Pass: Total) had a maximum possible score of 20, and the attempt at tying a microsurgical tie (Tie: Total) had a maximum possible score of 20, making 40 the maximum possible total score for each video (Total: Pass+Tie). The time each subject took to pass the needle, and the time each subject took to attempt tying a microsurgical tie was measured in number of seconds.
- Conditions
- Microsurgery
- Being tested
- Micro-stellated Icosahedron
- Keywords
- microsurgery, ophthalmology, medical education, surgical skills, surgical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-stellated IcosahedronOther
A portable, inexpensive microsurgery training model that requires the following materials for completion. a stereoscopic dissecting microscope, two jeweler style forceps, a pair of curved-tip micro scissors , 1 meter of monofilament nylon thread, 0.5 meter of polyimide microtubule material , one 15 cm metal ruler, a scalpel blade (#15), and double-sided tape. For a microsurgically-naive subject, a total of 20 hours are required to complete this model.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Subjects in the intervention group were tasked with building a micro-stellated icosahedron using a detailed instruction manual. They were each provided with a dissecting microscope and necessary materials to complete the task at home at their leisure. They were given two weeks to complete the task. They were asked to return for a second in-person meeting two weeks. Receives: Other: Micro-stellated Icosahedron |
| Control Group | No intervention | Subjects in the non-intervention control group were not given any task or any materials. They were asked to return for a second in-person meeting in two weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Objective Structure Assessment of Technical Skill (OSATS) scores for passing a needle.
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which grades the following four criteria with a score from 1 (minimum) to 5 (maximum): Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique. Therefore, by adding the grades for each of the four criteria, the total score for passing the needle (Pass: Total) had a minimum score of 4 and a maximum possible score of 20. Higher values represent better outcomes.
Both raters assigned scores for the participants' attempts at passing the needle through the incision in each video. The scores from the two raters were added. The sum of the scores were used to determine whether there was change in scores for each participant between pre-assessment and post-assessment videos. Higher scores represent a better outcome.
Measured: Two weeks
Change in Objective Structure Assessment of Technical Skill (OSATS) scores for making a microsurgical tie.
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which grades the following four criteria with a score from 1 (minimum) to 5 (maximum): Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique. Therefore, by adding the grades for each of the four criteria, the total score for making a microsurgical tie (Tie: Total) had a minimum score of 4 and a maximum possible score of 20. Higher values represent better outcomes.
Both raters assigned scores for the participants' attempts at making a microsurgical tie in each video. The scores from the two raters were added. The sum of the scores were used to determine whether there was change in scores for each participant between pre-assessment and post-assessment videos. Higher scores represent a better outcome.
Measured: Two weeks
Change in time required to pass a needle.
The time (in seconds) each subject took to pass the needle was measured from the time subject started manipulating the needle holder and toothed forceps to the time the subject began tying maneuvers.
The time (in seconds) was used to determine whether there was change in the amount of time each subject required to pass the needle between pre-assessment and post-assessment videos. Lower values represent better outcomes.
Measured: Two weeks
Change in time required to complete microsurgical tie.
The time (in seconds) each subject took to attempt tying a microsurgical tie was measured from the time the subject started manipulations for tying to the time the subject completed the microsurgical tie.
The time(in seconds) was used to determine whether there was change in the amount of time each subject required to make a microsurgical tie between pre-assessment and post-assessment videos. Lower values represent better outcomes.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start30 Jun 2017
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for MicrosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-center, prospective, randomized, controlled trial. After obtaining consent, recruited participants were asked to perform a microsurgical task. Their attempt was video-recorded for a pre-assessment. After completion of the video-recorded pre-assessment, participants were randomized to either the intervention or the non-intervention control group by flip of a coin. Subjects in the intervention group were tasked to build a micro-stellated icosahedron using a detailed instruction manual. Subjects in the control group had no specific task for two weeks. All subjects in both groups were required to return in two weeks for a second in-person meeting. At the second meeting, their attempt at completing a microsurgical task was video-recorded for a post-assessment, using similar instruments and set-up as those used two weeks prior.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangita Patel, State University of New York at Buffalo
- Investigators
- Sangita P Patel, MD, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093063
- Sponsor's protocol ID
- STUDY00001491
- Status last verified
- Oct 2020
- First submitted
- 16 Sep 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan WY, Matteucci P, Southern SJ. Validation of microsurgical models in microsurgery training and competence: a review. Microsurgery. 2007;27(5):494-9. doi: 10.1002/micr.20393.
PubMed 17596849Dumestre D, Yeung JK, Temple-Oberle C. Evidence-based microsurgical skill-acquisition series part 1: validated microsurgical models--a systematic review. J Surg Educ. 2014 May-Jun;71(3):329-38. doi: 10.1016/j.jsurg.2013.09.008. Epub 2014 Jan 4.
PubMed 24797848Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.
PubMed 15383395Ezra DG, Aggarwal R, Michaelides M, Okhravi N, Verma S, Benjamin L, Bloom P, Darzi A, Sullivan P. Skills acquisition and assessment after a microsurgical skills course for ophthalmology residents. Ophthalmology. 2009 Feb;116(2):257-62. doi: 10.1016/j.ophtha.2008.09.038. Epub 2008 Dec 16.
PubMed 19091411Benjamin L. Selection, teaching and training in ophthalmology. Clin Exp Ophthalmol. 2005 Oct;33(5):524-30. doi: 10.1111/j.1442-9071.2005.01089.x.
PubMed 16181283Belykh E, Byvaltsev V. Off-the-job microsurgical training on dry models: Siberian experience. World Neurosurg. 2014 Jul-Aug;82(1-2):20-4. doi: 10.1016/j.wneu.2014.01.018. Epub 2014 Feb 2.
PubMed 24495474White CA, Wrzosek JA, Chesnutt DA, Enyedi LB, Cabrera MT. A novel method for teaching key steps of strabismus surgery in the wet lab. J AAPOS. 2015 Oct;19(5):468-70.e1. doi: 10.1016/j.jaapos.2015.05.020.
PubMed 26486033Sikder S, Tuwairqi K, Al-Kahtani E, Myers WG, Banerjee P. Surgical simulators in cataract surgery training. Br J Ophthalmol. 2014 Feb;98(2):154-8. doi: 10.1136/bjophthalmol-2013-303700. Epub 2013 Oct 24.
PubMed 24158838Nandigam K, Soh J, Gensheimer WG, Ghazi A, Khalifa YM. Cost analysis of objective resident cataract surgery assessments. J Cataract Refract Surg. 2015 May;41(5):997-1003. doi: 10.1016/j.jcrs.2014.08.041.
PubMed 26049832McCannel CA. Continuous Curvilinear Capsulorhexis Training and Non-Rhexis Related Vitreous Loss: The Specificity of Virtual Reality Simulator Surgical Training (An American Ophthalmological Society Thesis). Trans Am Ophthalmol Soc. 2017 Aug 22;115:T2. eCollection 2017 Aug.
PubMed 29021716McCannel CA, Reed DC, Goldman DR. Ophthalmic surgery simulator training improves resident performance of capsulorhexis in the operating room. Ophthalmology. 2013 Dec;120(12):2456-2461. doi: 10.1016/j.ophtha.2013.05.003. Epub 2013 Jun 21.
PubMed 23796766Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
PubMed 18839484Rufer F, Schroder A, Erb C. White-to-white corneal diameter: normal values in healthy humans obtained with the Orbscan II topography system. Cornea. 2005 Apr;24(3):259-61. doi: 10.1097/01.ico.0000148312.01805.53.
PubMed 15778595Lannon DA, Atkins JA, Butler PE. Non-vital, prosthetic, and virtual reality models of microsurgical training. Microsurgery. 2001;21(8):389-93. doi: 10.1002/micr.21709.
PubMed 11757067Greyner-Almeida HD, Mahdavi Fard A, Chen C, Zhao J, Patel SP. A portable, low-cost practice model for microsurgical skills training. Int Ophthalmol. 2022 Aug;42(8):2323-2333. doi: 10.1007/s10792-022-02229-1. Epub 2022 Jan 29.
PubMed 35094230
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Inexpensive Practice Model for Microsurgical Skills Training: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04093063
- Acronym / sponsor ID
- STUDY00001491
- Conditions
- Microsurgery
- Keywords
- microsurgery, ophthalmology, medical education, surgical skills, surgical practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, prospective, randomized, controlled intervention trial to validate an inexpensive practice model for acquisition of microsurgical skills. Following a pre-assessment microsurgical skills task, participants were randomized to either an intervention group to build a micro-stellated icosahedron, or to a control group with no specific task assigned. A post-assessment microsurgical skills task was given to all participants after two weeks. Videos of pre- and post-assessments were masked and independently rated by two ophthalmologists using Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) scoring criteria. Analyses were done to determine improvement in time required to complete tasks and in scores between pre- and post- assessments.
Detailed description
This study is a single-center, prospective, randomized trial approved by the University at Buffalo Institutional Review Board. Medical students, residents and other interested individuals without prior microsurgery experience affiliated with the Jacobs School of Medicine and Biomedical Sciences were invited to participate. Each participant completed written informed consent.
Participants first watched an instructional video made by the Principal Investigator on how to pass a 9-0 nylon suture needle, and how to perform a microsurgical tie for a linear incision in a silicon baking mat using the same materials as would be provided to them for the pre- and post-assessments (Video 1). After watching the video three consecutive times, participants were tasked to pass and tie a 9-0 nylon suture in the same manner as the video recording. Their attempt at performing the microsurgical task was video-recorded for a pre-assessment with a cellphone camera focusing on the microscope field ensuring a clear view of the surgical field and the participant's instrument manipulation. Each subject wore gloves during the assessment to ensure anonymity.
After completion of the video-recorded pre-assessment, participants were randomized by flip of a coin to either the intervention group to build a micro-stellated icosahedron, or to the non-intervention control group with no assigned task. All subjects in both groups were required to return in two weeks for a second in-person meeting. At the second meeting, they were presented with the same instructional video as in the first meeting on how to pass a needle and perform a microsurgical tie. After watching the video three consecutive times, their attempt at completing a microsurgical tie was video-recorded for a post-assessment, using similar instruments and set-up as those used two weeks prior. Subjects in the intervention group were asked to return borrowed materials and their completed micro-stellated icosahedrons.
After all subjects were recruited, and their corresponding microsurgical tasks were video-recorded for pre- and post-assessments, each of the videos was edited to mute all audio in order to ensure anonymity. Each of the videos was de-identified by naming it with a random number from 1 to 42 and saved in a file folder in random order. This file folder was sent separately to two ophthalmologists, masked to the identity of the subjects (intervention vs control) and time of recording (pre- or post-assessment).
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which scores four criteria with scores from 1 to 5: Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique.4 The raters assigned separate scores for the participant's attempt at passing the needle through the incision, and for their attempt at tying a microsurgical tie. The attempt at passing the needle (Pass: Total) had a maximum possible score of 20, and the attempt at tying a microsurgical tie (Tie: Total) had a maximum possible score of 20, making 40 the maximum possible total score for each video (Total: Pass+Tie). The time each subject took to pass the needle, and the time each subject took to attempt tying a microsurgical tie was measured in number of seconds.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-center, prospective, randomized, controlled trial. After obtaining consent, recruited participants were asked to perform a microsurgical task. Their attempt was video-recorded for a pre-assessment. After completion of the video-recorded pre-assessment, participants were randomized to either the intervention or the non-intervention control group by flip of a coin. Subjects in the intervention group were tasked to build a micro-stellated icosahedron using a detailed instruction manual. Subjects in the control group had no specific task for two weeks. All subjects in both groups were required to return in two weeks for a second in-person meeting. At the second meeting, their attempt at completing a microsurgical task was video-recorded for a post-assessment, using similar instruments and set-up as those used two weeks prior.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Micro-stellated IcosahedronSubjects in the intervention group were tasked with building a micro-stellated icosahedron using a detailed instruction manual. They were each provided with a dissecting microscope and necessary materials to complete the task at home at their leisure. They were given two weeks to complete the task. They were asked to return for a second in-person meeting two weeks. |
| Control Group | No intervention | –Subjects in the non-intervention control group were not given any task or any materials. They were asked to return for a second in-person meeting in two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 year-old or older.
- No prior microsurgical experience.
Key exclusion criteria (1 listed)
- Prior microsurgical experience.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-stellated IcosahedronA portable, inexpensive microsurgery training model that requires the following materials for completion. a stereoscopic dissecting microscope, two jeweler style forceps, a pair of curved-tip micro scissors , 1 meter of monofilament nylon thread, 0.5 meter of polyimide microtubule material , one 15 cm metal ruler, a scalpel blade (#15), and double-sided tape. For a microsurgically-naive subject, a total of 20 hours are required to complete this model. | Other | Intervention Group |
Primary outcome
Change in Objective Structure Assessment of Technical Skill (OSATS) scores for passing a needle.
Time frame: Two weeks
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which grades the following four criteria with a score from 1 (minimum) to 5 (maximum): Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique. Therefore, by adding the grades for each of the four criteria, the total score for passing the needle (Pass: Total) had a minimum score of 4 and a maximum possible score of 20. Higher values represent better outcomes. Both raters assigned scores for the participants' attempts at passing the needle through the incision in each video. The scores from the two raters were added. The sum of the scores were used to determine whether there was change in scores for each participant between pre-assessment and post-assessment videos. Higher scores represent a better outcome.
Change in Objective Structure Assessment of Technical Skill (OSATS) scores for making a microsurgical tie.
Time frame: Two weeks
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which grades the following four criteria with a score from 1 (minimum) to 5 (maximum): Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique. Therefore, by adding the grades for each of the four criteria, the total score for making a microsurgical tie (Tie: Total) had a minimum score of 4 and a maximum possible score of 20. Higher values represent better outcomes. Both raters assigned scores for the participants' attempts at making a microsurgical tie in each video. The scores from the two raters were added. The sum of the scores were used to determine whether there was change in scores for each participant between pre-assessment and post-assessment videos. Higher scores represent a better outcome.
Change in time required to pass a needle.
Time frame: Two weeks
The time (in seconds) each subject took to pass the needle was measured from the time subject started manipulating the needle holder and toothed forceps to the time the subject began tying maneuvers. The time (in seconds) was used to determine whether there was change in the amount of time each subject required to pass the needle between pre-assessment and post-assessment videos. Lower values represent better outcomes.
Change in time required to complete microsurgical tie.
Time frame: Two weeks
The time (in seconds) each subject took to attempt tying a microsurgical tie was measured from the time the subject started manipulations for tying to the time the subject completed the microsurgical tie. The time(in seconds) was used to determine whether there was change in the amount of time each subject required to make a microsurgical tie between pre-assessment and post-assessment videos. Lower values represent better outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 17596849Chan WY, Matteucci P, Southern SJ. Validation of microsurgical models in microsurgery training and competence: a review. Microsurgery. 2007;27(5):494-9. doi: 10.1002/micr.20393.
- Background: PubMed 24797848Dumestre D, Yeung JK, Temple-Oberle C. Evidence-based microsurgical skill-acquisition series part 1: validated microsurgical models--a systematic review. J Surg Educ. 2014 May-Jun;71(3):329-38. doi: 10.1016/j.jsurg.2013.09.008. Epub 2014 Jan 4.
- Background: PubMed 15383395Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.
- Background: PubMed 19091411Ezra DG, Aggarwal R, Michaelides M, Okhravi N, Verma S, Benjamin L, Bloom P, Darzi A, Sullivan P. Skills acquisition and assessment after a microsurgical skills course for ophthalmology residents. Ophthalmology. 2009 Feb;116(2):257-62. doi: 10.1016/j.ophtha.2008.09.038. Epub 2008 Dec 16.
- Background: PubMed 16181283Benjamin L. Selection, teaching and training in ophthalmology. Clin Exp Ophthalmol. 2005 Oct;33(5):524-30. doi: 10.1111/j.1442-9071.2005.01089.x.
- Background: PubMed 24495474Belykh E, Byvaltsev V. Off-the-job microsurgical training on dry models: Siberian experience. World Neurosurg. 2014 Jul-Aug;82(1-2):20-4. doi: 10.1016/j.wneu.2014.01.018. Epub 2014 Feb 2.
- Background: PubMed 26486033White CA, Wrzosek JA, Chesnutt DA, Enyedi LB, Cabrera MT. A novel method for teaching key steps of strabismus surgery in the wet lab. J AAPOS. 2015 Oct;19(5):468-70.e1. doi: 10.1016/j.jaapos.2015.05.020.
- Background: PubMed 24158838Sikder S, Tuwairqi K, Al-Kahtani E, Myers WG, Banerjee P. Surgical simulators in cataract surgery training. Br J Ophthalmol. 2014 Feb;98(2):154-8. doi: 10.1136/bjophthalmol-2013-303700. Epub 2013 Oct 24.
- Background: PubMed 26049832Nandigam K, Soh J, Gensheimer WG, Ghazi A, Khalifa YM. Cost analysis of objective resident cataract surgery assessments. J Cataract Refract Surg. 2015 May;41(5):997-1003. doi: 10.1016/j.jcrs.2014.08.041.
- Background: PubMed 29021716McCannel CA. Continuous Curvilinear Capsulorhexis Training and Non-Rhexis Related Vitreous Loss: The Specificity of Virtual Reality Simulator Surgical Training (An American Ophthalmological Society Thesis). Trans Am Ophthalmol Soc. 2017 Aug 22;115:T2. eCollection 2017 Aug.
- Background: PubMed 23796766McCannel CA, Reed DC, Goldman DR. Ophthalmic surgery simulator training improves resident performance of capsulorhexis in the operating room. Ophthalmology. 2013 Dec;120(12):2456-2461. doi: 10.1016/j.ophtha.2013.05.003. Epub 2013 Jun 21.
- Background: PubMed 18839484Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangita P Patel, MD, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-stellated Icosahedron in people with Microsurgery, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective Structure Assessment of Technical Skill (OSATS) scores for passing a needle. (time frame: Two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093063, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.