Surgical Treatment of Concurrent Cataract and Primary Pterygium

NCT ID: NCT00563277

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-12-31

Brief Summary

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Pterygium is known to induce with-the-rule astigmatism. The corneal curvature along the long axis of the pterygium body is flattened. The excision of pterygium will result in steepening of the cornea and reduction of astigmatism. Therefore, the effect of pterygium excision on intraocular lens (IOL) power calculation has been examined in our previous study. The study confirmed that pterygium can cause alteration of IOL power.

The determination of IOL power for cataract surgery is usually calculated from IOL formula called SRK II formula. IOL power = A - (2.5 x AL)-(0.9 x K). Variable A denotes the A-constant of the intraocular lens which is dependent on the IOL material and refractive index. Other variables for input include axial length (AL) and keratometry (K). A larger K reading will result in a lower estimated IOL power and vice versa. Previous studies have documented simultaneous cataract and pterygium operation resulted in reasonable visual outcome without adjustment of IOL power.

With the presence of a pterygium, the cornea is flattened and lead to a reduction of K value and over-estimation of calculated IOL power. This randomized controlled trial is designed to compare the refractive outcomes of sequential and simultaneous pterygium and cataract operation.

Pterygium excision should be done with various adjuvant therapies to minimize recurrence. Our previous studies reliably demonstrated limbal conjunctival graft and mitomycin C were effective methods to achieve low pterygium recurrence. We use limbal conjunctival autograft as the adjuvant therapy in the current study because this method is safer to be performed either alone or in combination with phacoemulsification. We avoid using mitomycin C as the adjuvant therapy in order to minimize the possibility of intraocular toxicity due to seepage.

Detailed Description

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Conditions

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Pterygium Cataract Lenses, Intraocular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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combined pterygium and cataract operation

Intervention Type PROCEDURE

pterygium excision followed by cataract operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \>18 years old
* Primary pterygium \> 2mm across corneal limbus \[Measurement made from the imaginary line of surgical limbus to the most advance edge of the visible pterygium tissue\] Concurrent visually significant cataract ( BCVA \< 20/70 )
* Informed consent for both pterygium and cataract surgery

Exclusion Criteria

* Temporal pterygium
* Double headed pterygium
* Previous ocular surgery in which conjunctival-limbal graft is not feasible
* Pterygium covering visual axis that preclude keratometric assessment
* History of scleritis or autoimmune diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Lulu Cheng, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Alice Ho Miu Ling Nethersole Hospital

Hong Kong, , China

Site Status RECRUITING

Hong Kong Eye Hospital

Hong Kong, , China

Site Status RECRUITING

Prince of Wales Hospital

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lulu Cheng, Dr

Role: CONTACT

(852) 2632 2878

Other Identifiers

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HARECCTR0500012

Identifier Type: -

Identifier Source: secondary_id

CRE-2004.274-T

Identifier Type: -

Identifier Source: org_study_id

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