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Corneal AstigmatismNCT01122992

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

A study testing Limbal relaxing incision in people with Corneal Astigmatism, run by Singapore National Eye Centre at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Corneal Astigmatism
What is being tested?
Limbal relaxing incision
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteSingapore
Study dates
Nov 2006to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Wei Han Chua, FRCS Ophthalmology contact

+65 63228893

chua_wei_han@snec.com.sg

Singapore1 site, 1 recruiting
  • Singapore National Eye Centre

    Singapore, 168751

    Zainah Alsagoff, FRCS Ophthalmology

    Jocelyn chua, MRCS / MMED Ophthalmology

    Recruiting

Other trials in Singapore

About this study

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.

Being tested
Limbal relaxing incision
Keywords
Limbal relaxing incision, Astigmatic correction, Phacoemulsification surgery, Chinese eyes
Medical subject headings
Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Limbal relaxing incisionProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of surgically induced astigmatism at three months postop

    Measured: at three months postop

Secondary outcomes (2)
  1. Depth of LRI achieved at one month postop

    Measured: at one month postop

  2. Unaided visual acuity at three months postop

    Measured: at three months postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2010 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01122992
Sponsor's protocol ID
R489/38/2006
Status last verified
May 2010
First submitted
11 May 2010
Last updated
13 May 2010
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Limbal relaxing incision in people with Corneal Astigmatism, run by Singapore National Eye Centre at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Han Chua, FRCS Ophthalmology (+65 63228893, chua_wei_han@snec.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of surgically induced astigmatism at three months postop (time frame: at three months postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01122992, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2010.

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