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Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes

Primary Purpose

Corneal Astigmatism

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Limbal relaxing incision
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Astigmatism focused on measuring Limbal relaxing incision, Astigmatic correction, Phacoemulsification surgery, Chinese eyes

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Study subjects should be at least 21 years old, and not older than 60 years old
  • Only Chinese patients will be eligible for this study
  • Presence of a pre-existing regular astigmatism ranging between -1.00 to -3.00D
  • Informed consent obtained for both phacoemulsification surgery and LRI procedure
  • Study subject is agreeable to comply with the postoperative follow-up regime stated
  • Absence of any exclusion criteria

Exclusion Criteria:

  • Presence of irregular astigmatism
  • Pre-existing pterygium
  • Previous corneal / anterior segment surgery
  • Pre-existing corneal scar
  • Pre-existing corneal pathology eg keratoconus, Fuch's endothelial dystrophy, PUK, etc
  • Pre-existing glaucoma

Sites / Locations

  • Singapore National Eye CentreRecruiting

Outcomes

Primary Outcome Measures

Amount of surgically induced astigmatism at three months postop

Secondary Outcome Measures

Depth of LRI achieved at one month postop
Unaided visual acuity at three months postop

Full Information

First Posted
May 11, 2010
Last Updated
May 12, 2010
Sponsor
Singapore National Eye Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01122992
Brief Title
Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes
Official Title
Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Singapore National Eye Centre

4. Oversight

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the use of limbal relaxing incision (LRI) for astigmatic correction. LRI is a procedure where a pair of incisions is made in the peripheral part of the cornea so as to alter its shape and improve the focusing power of the eye.
Detailed Description
An important aim in cataract surgery has always been a good postoperative visual outcome. Efforts have been made to achieve this, with the introduction of intraocular lens in the 1980s and small incision cataract surgery in the 1990s. In the recent years, 'refractive' cataract surgery has taken the form of corneal astigmatic correction. Patients with pre-existing astigmatism of more than 1.5D may benefit from surgical correction during cataract surgery, in the hope of improving uncorrected visual acuity as well as lesser image distortion from corneal aberrations. The limbal relaxing incisional technique involves placement of incisions corresponding to the steep meridian, thereby resulting in corneal flattening and reduction of astigmatic power. It is increasingly popular due to its advantages. LRI is simple to perform, very safe procedure in experienced hands, effective for astigmatic reduction of up to 4D, has rapid visual rehabilitation and is associated with very few visual complications due to the peripheral location of the incisions. Possible complications include globe weakening, corneal perforation, worsening of astigmatism, incorrect incisional placement and corneal hypoesthesia. LRI technique and the practical nomograms has been described and made feasible by both James P Gills and Louis D Nichamin. Based on preoperatively measured astigmatic power and axis, these two nomograms recommend a systematic approach to the amount of surgical correction required. The reason for the Nichamin nomogram being more frequently applied, can be attributed to a few inherent features. It accounts for the age of the patient as a surgical variability and recommends the use of paired arcuate limbal incisions measured in degrees of arc. Paired incisions enable symmetric corneal flattening at the steep meridian, whilst arcuate incisions are more physiological, thereby resulting in accurate astigmatic correction that is independent of corneal diameter. Nichamin has also implemented a modified Nichamin age and pachymetry-adjusted nomogram (otherwise known as 'NAPA' nomogram). It accounts for the patient's peripheral corneal thickness and adjusts the incisional depth accordingly to achieve 90% of corneal thickness. Many studies have shown that LRI is an effective option for astigmatic correction in Caucasian eyes. Whether these results can be further extrapolated to apply to Chinese eyes are still largely uncertain. To date, there has not been a formal study conducted to evaluate this hypothesis. Moreover, there has been some anecdotal evidence suggesting less favorable postoperative outcome of LRI in Chinese eyes. The main objective of our study is thus to assess the utility and effectiveness of LRI in Chinese eyes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Astigmatism
Keywords
Limbal relaxing incision, Astigmatic correction, Phacoemulsification surgery, Chinese eyes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Limbal relaxing incision
Primary Outcome Measure Information:
Title
Amount of surgically induced astigmatism at three months postop
Time Frame
at three months postop
Secondary Outcome Measure Information:
Title
Depth of LRI achieved at one month postop
Time Frame
at one month postop
Title
Unaided visual acuity at three months postop
Time Frame
at three months postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Study subjects should be at least 21 years old, and not older than 60 years old Only Chinese patients will be eligible for this study Presence of a pre-existing regular astigmatism ranging between -1.00 to -3.00D Informed consent obtained for both phacoemulsification surgery and LRI procedure Study subject is agreeable to comply with the postoperative follow-up regime stated Absence of any exclusion criteria Exclusion Criteria: Presence of irregular astigmatism Pre-existing pterygium Previous corneal / anterior segment surgery Pre-existing corneal scar Pre-existing corneal pathology eg keratoconus, Fuch's endothelial dystrophy, PUK, etc Pre-existing glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Han Chua, FRCS Ophthalmology
Phone
+65 63228893
Email
chua_wei_han@snec.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Han Chua, FRCS Ophthalmology
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zainah Alsagoff, FRCS Ophthalmology
First Name & Middle Initial & Last Name & Degree
Jocelyn chua, MRCS / MMED Ophthalmology

12. IPD Sharing Statement

Citations:
PubMed Identifier
10504084
Citation
Muller-Jensen K, Fischer P, Siepe U. Limbal relaxing incisions to correct astigmatism in clear corneal cataract surgery. J Refract Surg. 1999 Sep-Oct;15(5):586-9. doi: 10.3928/1081-597X-19990901-12.
Results Reference
result
PubMed Identifier
11807381
Citation
Gills JP. Treating astigmatism at the time of cataract surgery. Curr Opin Ophthalmol. 2002 Feb;13(1):2-6. doi: 10.1097/00055735-200202000-00002.
Results Reference
result
PubMed Identifier
9584246
Citation
Budak K, Friedman NJ, Koch DD. Limbal relaxing incisions with cataract surgery. J Cataract Refract Surg. 1998 Apr;24(4):503-8. doi: 10.1016/s0886-3350(98)80292-7.
Results Reference
result

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Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes

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