Comparing two devices for measuring eye parameters before cataract surgery
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
NA · Walailak University · NCT06377007
This study is testing which of two eye measurement devices, the Argos or the IOLMaster 700, does a better job at helping people get the right lens power for their cataract surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Walailak University (other) |
| Locations | 1 site (Nakhon Si Thammarat) |
| Trial ID | NCT06377007 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of two different swept-source optical coherence tomography (SS-OCT) biometers, the Argos and the IOLMaster 700, in predicting the optimal intraocular lens (IOL) power for cataract surgery. Patients undergoing cataract surgery will have their eye measurements taken using both devices in a randomized order. The study aims to determine which device provides more precise biometry outcomes to ensure the best visual results post-surgery. Refractive and visual outcomes will be assessed 28 to 42 days after the surgery.
Who should consider this trial
Good fit: Ideal candidates include patients with cataracts or presbyopia who are scheduled for intraocular lens implantation.
Not a fit: Patients with certain eye conditions, such as severe dry eye or prior corneal refractive surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the precision of IOL power selection, leading to improved visual outcomes for cataract surgery patients.
How similar studies have performed: Other studies have shown success in using advanced biometric devices for cataract surgery, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Patients with cataract and/or presbyopia who will undergo intraocular lens implantation. Exclusion Criteria: * Central corneal thickness less than 490 mm or greater than 600 mm * Contact lens use within 2 months of cataract surgery * Severe dry eye * Corneal or retinal disease affecting visual outcome * Corneal astigmatism greater than 1.00 D * Prior corneal refractive surgery * Dense cataract that does not allow measurements to be taken with an optical biometrics system.
Where this trial is running
Nakhon Si Thammarat
- Walailak University — Nakhon Si Thammarat, Thailand (RECRUITING)
Study contacts
- Study coordinator: Jakkrit Juhong, MD.
- Email: jakkrit.ju@wu.ac.th
- Phone: 0816773406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract, Biometry, SS-OCT, IOLMaster700, Argos