search
Back to results

Surgical Treatment of Concurrent Cataract and Primary Pterygium

Primary Purpose

Pterygium, Cataract, Lenses, Intraocular

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
combined pterygium and cataract operation
pterygium excision followed by cataract operation
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium, Cataract, Intraocular lens power calculation accuracy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Alice Ho Miu Ling Nethersole HospitalRecruiting
  • Hong Kong Eye HospitalRecruiting
  • Prince of Wales HospitalRecruiting

Outcomes

Primary Outcome Measures

final refraction deviation from target

Secondary Outcome Measures

change of IOL power from pre-pterygium estimated power

Full Information

First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT00563277
Brief Title
Surgical Treatment of Concurrent Cataract and Primary Pterygium
Official Title
Surgical Treatment of Concurrent Cataract and Primary Pterygium: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Cataract, Lenses, Intraocular
Keywords
Pterygium, Cataract, Intraocular lens power calculation accuracy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
combined pterygium and cataract operation
Intervention Type
Procedure
Intervention Name(s)
pterygium excision followed by cataract operation
Primary Outcome Measure Information:
Title
final refraction deviation from target
Time Frame
1 and 3 months post cataract operation
Secondary Outcome Measure Information:
Title
change of IOL power from pre-pterygium estimated power
Time Frame
1 and 3 months post pterygium excision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lulu Cheng, Dr
Phone
(852) 2632 2878
Email
chenglu@i-cable.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lulu Cheng, Dr
Organizational Affiliation
Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Name
Hong Kong Eye Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Lam, Prof
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvin Young, Dr
First Name & Middle Initial & Last Name & Degree
Gloria Leung, Dr
First Name & Middle Initial & Last Name & Degree
Arthur Cheng, Prof

12. IPD Sharing Statement

Learn more about this trial

Surgical Treatment of Concurrent Cataract and Primary Pterygium

We'll reach out to this number within 24 hrs