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.
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.
Singapore1 site, 1 recruiting
- Recruiting
Singapore National Eye Centre
Singapore, 168751
Zainah Alsagoff, FRCS Ophthalmology
Jocelyn chua, MRCS / MMED Ophthalmology
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.
- Conditions
- Corneal Astigmatism
- 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.
Amount of surgically induced astigmatism at three months postop
Measured: at three months postop
Secondary outcomes (2)
Depth of LRI achieved at one month postop
Measured: at one month postop
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.
- First posted13 May 2010 (estimated)
- Study startNov 2006
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Wei Han Chua, FRCS Ophthalmology, Principal investigator, Singapore National Eye Centre
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 10504084Gills 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 11807381Budak 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes
- ClinicalTrials.gov ID
- NCT01122992
- Acronym / sponsor ID
- R489/38/2006
- Conditions
- Corneal Astigmatism
- Keywords
- Limbal relaxing incision, Astigmatic correction, Phacoemulsification surgery, Chinese eyes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Nov 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limbal relaxing incision | Procedure or surgery | – |
Primary outcome
Amount of surgically induced astigmatism at three months postop
Time frame: at three months postop
2 secondary outcomes
Depth of LRI achieved at one month postop
Time frame: at one month postop
Unaided visual acuity at three months postop
Time frame: at three months postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2010.
- Results publication: PubMed 10504084Muller-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 publication: PubMed 11807381Gills 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 publication: PubMed 9584246Budak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Han Chua, FRCS Ophthalmology principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
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.