Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMay 13, 2010
May 1, 2010
4.1 years
May 11, 2010
May 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of surgically induced astigmatism at three months postop
at three months postop
Secondary Outcomes (2)
Depth of LRI achieved at one month postop
at one month postop
Unaided visual acuity at three months postop
at three months postop
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore National Eye Centre
Singapore, 168751, Singapore
Related Publications (3)
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.
PMID: 10504084RESULTGills JP. Treating astigmatism at the time of cataract surgery. Curr Opin Ophthalmol. 2002 Feb;13(1):2-6. doi: 10.1097/00055735-200202000-00002.
PMID: 11807381RESULTBudak 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.
PMID: 9584246RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Han Chua, FRCS Ophthalmology
Singapore National Eye Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 11, 2010
First Posted
May 13, 2010
Study Start
November 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
May 13, 2010
Record last verified: 2010-05