Surgical Treatment of Concurrent Cataract and Primary Pterygium
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pterygium Cataract Lenses, Intraocular |
Procedure: combined pterygium and cataract operation Procedure: pterygium excision followed by cataract operation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Surgical Treatment of Concurrent Cataract and Primary Pterygium: A Randomized Control Trial |
- final refraction deviation from target [ Time Frame: 1 and 3 months post cataract operation ]
- change of IOL power from pre-pterygium estimated power [ Time Frame: 1 and 3 months post pterygium excision ]
| Estimated Enrollment: | 75 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | December 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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
Contacts and Locations| Contact: Lulu Cheng, Dr | (852) 2632 2878 | chenglu@i-cable.com |
| China | |
| Prince of Wales Hospital | Recruiting |
| Hong Kong, China | |
| Sub-Investigator: Alvin Young, Dr | |
| Sub-Investigator: Gloria Leung, Dr | |
| Sub-Investigator: Arthur Cheng, Prof | |
| Alice Ho Miu Ling Nethersole Hospital | Recruiting |
| Hong Kong, China | |
| Hong Kong Eye Hospital | Recruiting |
| Hong Kong, China | |
| Sub-Investigator: Dennis Lam, Prof | |
| Principal Investigator: | Lulu Cheng, Dr | Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00563277 History of Changes |
| Other Study ID Numbers: | CRE-2004.274-T, HARECCTR0500012 |
| Study First Received: | November 21, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
Pterygium Cataract Intraocular lens power calculation accuracy |
Additional relevant MeSH terms:
|
Pterygium Cataract Conjunctival Diseases Eye Diseases Lens Diseases |
ClinicalTrials.gov processed this record on May 16, 2013