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Accuracy of Holladay 2 Formula in the Absence of Lens Thickness

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
optical biometric measurement (IOLMaster)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataracts

Eligibility Criteria

44 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with cataract

Exclusion Criteria:

  • previous ocular diseases
  • previous ocular surgery

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mean absolute errors, median absolute errors

Arm Description

Outcomes

Primary Outcome Measures

mean absolute error of Holladay2 formula
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2013
Last Updated
May 2, 2013
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01846078
Brief Title
Accuracy of Holladay 2 Formula in the Absence of Lens Thickness
Official Title
Accuracy of Holladay 2 Formula Using IOLMaster Parameters in the Absence of Lens Thickness
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mean absolute errors, median absolute errors
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
optical biometric measurement (IOLMaster)
Intervention Description
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
Primary Outcome Measure Information:
Title
mean absolute error of Holladay2 formula
Description
IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with cataract Exclusion Criteria: previous ocular diseases previous ocular surgery
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17137982
Citation
Narvaez 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. doi: 10.1016/j.jcrs.2006.09.009.
Results Reference
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Accuracy of Holladay 2 Formula in the Absence of Lens Thickness

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