Surgical Treatment of Concurrent Cataract and Primary Pterygium

Cataract Clinical Trial

Official title:

Surgical Treatment of Concurrent Cataract and Primary Pterygium: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00563277
• Other study ID #: CRE-2004.274-T
• Secondary ID: HARECCTR0500012
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2007
• Last updated: July 6, 2010
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Lulu Cheng, Dr
• Phone: (852) 2632 2878
• Email: chenglu[@]i-cable.com
• 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Lenses, Intraocular
• Pterygium

Intervention

Procedure:
• combined pterygium and cataract operation

• pterygium excision followed by cataract operation

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	final refraction deviation from target		1 and 3 months post cataract operation
Secondary	change of IOL power from pre-pterygium estimated power		1 and 3 months post pterygium excision

External Links

•   HAREC Clinical Trial Registry