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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01122992
Enrollment
30
Registered
2010-05-13
Start date
2006-11-30
Completion date
2010-12-31
Last updated
2010-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Astigmatism

Keywords

Limbal relaxing incision, Astigmatic correction, Phacoemulsification surgery, Chinese eyes

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.

Interventions

Sponsors

Singapore National Eye Centre
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Amount of surgically induced astigmatism at three months postopat three months postop

Secondary

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

Countries

Singapore

Contacts

Primary ContactWei Han Chua, FRCS Ophthalmology
chua_wei_han@snec.com.sg+65 63228893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026