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Status unknownNCT01122992Updated May 13, 2010

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

An interventional study of Limbal relaxing incision in Corneal Astigmatism, sponsored by Singapore National Eye Centre. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-13.

Sponsored by Singapore National Eye Centre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Corneal Astigmatism

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Keywords

  • Limbal relaxing incision
  • Astigmatic correction
  • Phacoemulsification surgery
  • Chinese eyes
03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's planned enrollment of 30 is below the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Singapore National Eye Centre is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • ProcedureLimbal relaxing incision
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What researchers measure

Primary outcomes

  1. Amount of surgically induced astigmatism at three months postop

    Time frame: at three months postop

Secondary outcomes

  1. Depth of LRI achieved at one month postop

    Time frame: at one month postop

  2. Unaided visual acuity at three months postop

    Time frame: at three months postop

07

Study locations

1 of 1 sites recruiting
  • Singapore National Eye Centre
    Singapore, 168751, Singapore
    • Zainah Alsagoff, FRCS Ophthalmology · Principal investigator
    • Jocelyn chua, MRCS / MMED Ophthalmology · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 10504084 ↗
  • 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. PubMed 11807381 ↗
  • 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. PubMed 9584246 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01122992
Lead sponsor
Singapore National Eye Centre
First posted
May 13, 2010
Start date
Nov 2006
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
May 13, 2010

Study contacts

Wei Han Chua, FRCS Ophthalmology
Contact
chua_wei_han@snec.com.sg
+65 63228893
Wei Han Chua, FRCS Ophthalmology
principal investigator · Singapore National Eye Centre
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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