NCT00563667

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

PterygiumCataractAstigmatism

Keywords

PterygiumCataractAstigmatism

Outcome Measures

Primary Outcomes (2)

  • IOL power

    1 and 3 months post pterygium excision

  • Astigmatism

    1 and 3 months post pterygium excision

Interventions

pterygium excisionPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, China

Location

Hong Kong Eye Hospital

Hong Kong, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

PterygiumCataractAstigmatism

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesLens DiseasesRefractive Errors

Study Officials

  • Lulu Cheng, Dr

    Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

December 1, 2003

Study Completion

December 1, 2004

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(3)