- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563277
Surgical Treatment of Concurrent Cataract and Primary Pterygium
Surgical Treatment of Concurrent Cataract and Primary Pterygium: A Randomized Control Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lulu Cheng, Dr
- Phone Number: (852) 2632 2878
- Email: chenglu@i-cable.com
Study Locations
-
-
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Hong Kong, China
- Recruiting
- Prince of Wales Hospital
-
Sub-Investigator:
- Alvin Young, Dr
-
Sub-Investigator:
- Gloria Leung, Dr
-
Sub-Investigator:
- Arthur Cheng, Prof
-
Hong Kong, China
- Recruiting
- Alice Ho Miu Ling Nethersole Hospital
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Hong Kong, China
- Recruiting
- Hong Kong Eye Hospital
-
Sub-Investigator:
- Dennis Lam, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
final refraction deviation from target
Time Frame: 1 and 3 months post cataract operation
|
1 and 3 months post cataract operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change of IOL power from pre-pterygium estimated power
Time Frame: 1 and 3 months post pterygium excision
|
1 and 3 months post pterygium excision
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lulu Cheng, Dr, Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2004.274-T
- HARECCTR0500012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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