NCT01846078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

April 30, 2013

Last Update Submit

May 2, 2013

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

  • mean absolute error of Holladay2 formula

    IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.

    6 months

Study Arms (1)

Mean absolute errors, median absolute errors

EXPERIMENTAL
Device: optical biometric measurement (IOLMaster)

Interventions

optical biometric measurement (IOLMaster)DEVICE

IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.

Mean absolute errors, median absolute errors

Eligibility Criteria

Age44 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cataract

You may not qualify if:

  • previous ocular diseases
  • previous ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 17137982BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Sabong Srivannaboon

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

June 1, 2012

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

TH(1)