Accuracy of Holladay 2 Formula in the Absence of Lens Thickness

Cataracts Clinical Trial

Official title:

Accuracy of Holladay 2 Formula Using IOLMaster Parameters in the Absence of Lens Thickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846078
• Other study ID #: Si343/2012
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: May 2, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 44 Years to 89 Years

Eligibility

Inclusion Criteria:

• patients with cataract

Exclusion Criteria:

• previous ocular diseases

• previous ocular surgery

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aphakia
• Cataracts

Intervention

Device:
• optical biometric measurement (IOLMaster)
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Narváez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006 Dec;32(12):2050-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean absolute error of Holladay2 formula	IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.	6 months	Yes