Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377007
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-01-30
Brief Title:
Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices ORION
Sponsor:
Walailak University
Organization:
Walailak University
Study Overview
Official Title:
Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices ORION A Non-Inferiority Randomized Clinical Trials
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION
Brief Summary:
Cataract surgery represents a common surgical intervention encompassing the extraction of the opaque natural crystalline lens followed by the substitution with an artificial intraocular lens IOL To ascertain an IOL possessing optimal power antecedent to the surgery preoperative evaluations are conducted through the utilization of a biometric devices Diverse categories of these instruments are accessible each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry
Detailed Description:
Two swept-source optical coherence tomography SS-OCT biometers namely the Argos and the IOLMaster 700 will be employed for the preoperative assessment of the eyes of all subjects who will undergo cataract surgery at the Eye Outpatient Department OPD of Walailak University Hospital The sequence of biometry measurements will be randomized among the subjects In Group 1 measurements will be initially conducted using the Argos device followed by the IOLMaster 700 device Conversely Group 2 subjects will undergo measurements with the IOLMaster 700 device first followed by the Argos device The sequence will be continuous without any breaks The analysis will encompass the right eyes of each subject
For the purpose of preoperative planning the Argos device will utilize the Barrett Universal Formula II K whereas the IOLMaster 700 device will employ the Barrett Universal II TK formula The objective for all eyes will be to achieve a plano outcome In instances where the suggested intraocular lens IOL power differs between the two biometers the IOL power recommended by the IOLMaster 700 device will be selected Cataract surgeries will be exclusively performed by a seasoned surgeon SM who will adhere to a consistent approach involving a clear temporal incision 275 mm followed by manual capsulorhexis Refractive and visual outcomes will be evaluated within a postoperative timeframe of 28 to 42 days Subjective refractions will be conducted by an optometrist ensuring blinding to the biometry data
The primary endpoint of this study will be the mean absolute prediction error exhibited by each SS-OCT biometer The computation of the absolute prediction error will involve determining the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction manifest Secondary objectives will encompass the median absolute prediction error and the proportion of eyes with an absolute prediction error equal to or less than 025 D and 05 D
For the purpose of preoperative planning the Argos device will utilize the Barrett Universal Formula II K whereas the IOLMaster 700 device will employ the Barrett Universal II TK formula The objective for all eyes will be to achieve a plano outcome In instances where the suggested intraocular lens IOL power differs between the two biometers the IOL power recommended by the IOLMaster 700 device will be selected Cataract surgeries will be exclusively performed by a seasoned surgeon SM who will adhere to a consistent approach involving a clear temporal incision 275 mm followed by manual capsulorhexis Refractive and visual outcomes will be evaluated within a postoperative timeframe of 28 to 42 days Subjective refractions will be conducted by an optometrist ensuring blinding to the biometry data
The primary endpoint of this study will be the mean absolute prediction error exhibited by each SS-OCT biometer The computation of the absolute prediction error will involve determining the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction manifest Secondary objectives will encompass the median absolute prediction error and the proportion of eyes with an absolute prediction error equal to or less than 025 D and 05 D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WU66290 | OTHER_GRANT | Walailak individual grant | None |