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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)

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

NCT ID

NCT01846078

First Posted

April 30, 2013

Last Updated

May 2, 2013

Sponsor

Mahidol University

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

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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