robert rivera md ascrs symposium & congress boston 2010 the author has received research...
TRANSCRIPT
Sizing Nomogram for ICL Vault Determination Using Sizing Nomogram for ICL Vault Determination Using Sulcus-to-Sulcus Measurements Obtained with High Sulcus-to-Sulcus Measurements Obtained with High
Frequency UltrasoundFrequency Ultrasound
Robert Rivera MDRobert Rivera MD
ASCRS Symposium & CongressASCRS Symposium & CongressBoston 2010Boston 2010
The author has received research support, travel support, The author has received research support, travel support, honoraria and consulting fees from the following:honoraria and consulting fees from the following:
Sonomed, STAAR Surgical, AlconSonomed, STAAR Surgical, Alcon
Sizing of the Visian ICLSizing of the Visian ICL
• ICL size chosen for implantation is based on white-to-white (WTW) measurement– US FDA Clinical Study was based on WTW– FDA approval based on WTW
• Assumption was that surface WTW measurement would closely follow sulcus-to-sulcus (STS) length
• Subsequent results and studies have shown this is not a valid assumption
• Note that UBM technology was not available in earlier days of ICL implantation; WTW was the best approximation available
Sizing of the Visian ICLSizing of the Visian ICL
• 17% of patients in the US clinical trial did not have optimal vault (90-1000 µ)
• Gonvers, et al, 2003 75 ICL cases, 27% cataract rate, all cataracts
had vaults less than 90 µ• Choi and Chung, 2007
– ICL length determined by UBM achieved ideal vault compared to conventional WTW
– 100% of UBM group had ideal vault after 6 months, compared to 52.9% in the WTW group
Ideal VaultIdeal Vault• Truly “ideal” vault would be 500 µ• Inadequate vault defined as <90 µ (Gonvers 27%
cataract rate = vaults less than 90 µ)• Excessive vault defined as >1000 µ (Choi, Chung, Chung
& Chung)• “Good” vault range 90-1000 µ
Development of a Sizing NomogramDevelopment of a Sizing Nomogram
• Retrospective Study– 73 eyes of 48 subjects with STS and vault
measurements taken on Sonomed VuMax II• Matamoros regression equation
– Modified with input from experienced ICL and Sonomed users
– Outcome analysis used to generate a spreadsheet of ideal ICL length, based upon STS measurements
Multi-Center Prospective Multi-Center Prospective Analysis of UBM for ICL SizingAnalysis of UBM for ICL Sizing
• Prospective multi-center trial• Sonomed VuMax II used to image sulcus images• Investigators:
– David Brown, MD– Paul Dougherty, MD – Stephen Lane, MD – Robert Rivera, MD– David Schneider, MD– John Vukich, MD
• 61 eyes of 61 subjects• Age 21-45• Average myopia treated –7.6D• No history of previous refractive surgery• IRB approval and informed consent obtained• 1 eye excluded
– Wrong length ICL placed – Nomogram suggested 13.2mm– 12.6mm ICL implanted
Subject had 0 vault
Prospective StudyProspective Study
• If the FDA label WTW method of sizing ICLs was used, 65% of cases would have received a different size
ICL than the STS Method, potentially requiring explantation in a significant number of patients
• If the improved PreVize Optimized WTW method of sizing ICLs was used,
34% of cases would have received a different size ICL than the STS Method
• Poor correlation (R2 value) between STS and ATA (58%); STS and WTW (46%)
Results of STS vs. WTW MethodsResults of STS vs. WTW Methods
ConclusionsConclusions
• Using our Sonomed study nomogram derived from STS Measurements, no cases fell within an unacceptable range of ICL vault compared to a reported 15%-20% of cases based upon WTW measurements
• Average Vault was 344 µ (range 93-952) • WTW methods would have resulted in different
sized ICLs in 34% to 65% of cases compared to the STS method
ConclusionsConclusions
• Further refinement of nomogram may allow improvement in higher and lower ranges of vault
• UBM STS measurements are far superior to WTW for the purposes of ICL selection with a far greater margin of safety
• Despite the FDA label, surface WTW measurements may lead to incorrect ICL selection in a significant percentage of patients
• In our opinion, careful systematic UBM STS should become the standard of care in ICL size selection
Thank [email protected]