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Effect of Pterygium Excision on Intraocular Lens Power Calculation for Subsequent Cataract Operation

Primary Purpose

Pterygium, Cataract, Astigmatism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pterygium excision
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium, Cataract, Astigmatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • All cases with concomitant cataract and primary pterygium, which are indicated for surgery.

Exclusion Criteria:

  • Pterygium smaller than 1mm, which is not visually significant.
  • Double headed pterygium
  • Pterygium obscuring visual axis that preclude keratometry or autorefraction measurements.
  • Previous corneal refractive surgery that alter the keratometric power of the cornea.
  • Patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.

Sites / Locations

  • Alice Ho Miu Ling Nethersole Hospital
  • Hong Kong Eye Hospital
  • Prince of Wales Hospital

Outcomes

Primary Outcome Measures

IOL power
Astigmatism

Secondary Outcome Measures

Full Information

First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00563667
Brief Title
Effect of Pterygium Excision on Intraocular Lens Power Calculation for Subsequent Cataract Operation
Official Title
Effect of Pterygium Excision on IOL Power Calculation: Concurrent Cataract and Pterygium
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong

4. Oversight

5. Study Description

Brief Summary
Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry reading will indirectly affect the IOL power calculation in cases with concurrent pterygium and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical regions. The effect of pterygium excision on intraocular lens power calculation is investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Cataract, Astigmatism
Keywords
Pterygium, Cataract, Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
pterygium excision
Primary Outcome Measure Information:
Title
IOL power
Time Frame
1 and 3 months post pterygium excision
Title
Astigmatism
Time Frame
1 and 3 months post pterygium excision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: All cases with concomitant cataract and primary pterygium, which are indicated for surgery. Exclusion Criteria: Pterygium smaller than 1mm, which is not visually significant. Double headed pterygium Pterygium obscuring visual axis that preclude keratometry or autorefraction measurements. Previous corneal refractive surgery that alter the keratometric power of the cornea. Patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lulu Cheng, Dr
Organizational Affiliation
Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
China
Facility Name
Hong Kong Eye Hospital
City
Hong Kong
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Effect of Pterygium Excision on Intraocular Lens Power Calculation for Subsequent Cataract Operation

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