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Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Honan balloon application

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

cataract patient,who plan to undergo phacoemulsification
no previous ocular surgery

Exclusion Criteria:

one eye
high myopia
Use ASA or anticoagulants
History of glaucoma or ocular hypertension
uncooperative patients

Sites / Locations

King Chulalongkorn Memorial hospital

Outcomes

Primary Outcome Measures

intraocular pressure reduction

Secondary Outcome Measures

pain score

Full Information

NCT ID

NCT00386438

First Posted

October 10, 2006

Last Updated

October 10, 2006

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT00386438

Brief Title

Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Chulalongkorn University

4. Oversight

5. Study Description

Brief Summary

-Does Honan balloon reduce intraocular pressure preoperatively?

Detailed Description

-Does Honan balloon improve surgeon's satisfaction and patients' pain score when compared to no honan group?

6. Conditions and Keywords

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

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Honan balloon application

Primary Outcome Measure Information:

Title

intraocular pressure reduction

Secondary Outcome Measure Information:

Title

pain score

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: cataract patient,who plan to undergo phacoemulsification no previous ocular surgery Exclusion Criteria: one eye high myopia Use ASA or anticoagulants History of glaucoma or ocular hypertension uncooperative patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thitima Lunchakonsiripan, MD

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

King Chulalongkorn Memorial hospital

City

Patumwan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Links:

URL

http://www.md.chula.ac.th

Description

Faculty of Medicine,Chulalongkorn University

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Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification

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