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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00563667
Other study ID # CRE-2003.353
Secondary ID HARECCTR0500013
Status Active, not recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date December 2003
Est. completion date December 2004

Study information

Verified date July 2010
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
pterygium excision


Locations

Country Name City State
China Alice Ho Miu Ling Nethersole Hospital Hong Kong
China Hong Kong Eye Hospital Hong Kong
China Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary IOL power 1 and 3 months post pterygium excision
Primary Astigmatism 1 and 3 months post pterygium excision
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