Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-08-31

Brief Summary

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We would like to evaluate the use of a 600μm pre-cut regarding wound architecture and surgically induced astigmatism as compared to a stab-incision (a corneal incision without a pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration.

Postoperatively, OCT scans will be obtained, corneal curvature will be measured and subjective and objective refraction will be performed in order to measure the surgically-induced astigmatism.

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Detailed Description

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Corneal wound architecture in cataract surgery has recently been assessed1-4 using optical coherence tomography. However, none of these studies observed the effect of the wound architecture on postoperative astigmatism. In a previous study performed at our center, cataract surgery using a 1.8 mm micro incision (MICS) was compared to a 2.5 mm standard incision (SICS) regarding wound architecture and surgically induced astigmatism. Wound size and wound architecture were assessed using a Time-Domain OCT intraand postoperatively. After implantation of the IOL the incisions were shown to be larger than planned.

This effect was shown to be more pronounced in the small incision group. Both epithelial and endothelial wound gaping at the end of surgery occurred more often in the MICS group. Furthermore, this study showed no effect of a 300 μm pre-cut on postoperative wound architecture and surgically induced astigmatism. Based on these findings we would like to perform another study using a high-resolution Spectral-Domain OCT, which allows for a three-dimensional depiction of wound architecture and a better understanding of the dynamic changes in wound structure during surgery. Furthermore a new high resolution OCT device will be available outside the operating theatre for postoperative measurements. Both devices are CE certified, will be used according to their indication and allow noncontact and therefore pain free measurements. As no significant impact of a 300μm pre-cut on wound architecture and astigmatism was shown in the predecessor study, we would like to evaluate the use of a 600μm pre-cut regarding wound architecture and surgically induced astigmatism as compared to a stab-incision (a corneal incision without a pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration.

Postoperatively, OCT scans will be obtained, corneal curvature will be measured and subjective and objective refraction will be performed in order to measure the surgically-induced astigmatism.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Precut

A corneal precut of 600µm will be performed.

Group Type ACTIVE_COMPARATOR

Corneal precut 600µm

Intervention Type PROCEDURE

Stab incision

A stab incision without corneal precut will be performed.

Group Type ACTIVE_COMPARATOR

Corneal stabincision

Intervention Type PROCEDURE

Interventions

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Corneal precut 600µm

Intervention Type PROCEDURE

Corneal stabincision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age-related cataract
* Age 21 and older
* written informed consent prior to recruitment

Exclusion Criteria

* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
* Any ophthalmic abnormality that could compromise the measurements

Minimum Eligible Age

21 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No