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

Sponsor

Prim. Prof. Dr. Oliver Findl, MBA (Other)

Overall Status

Completed

CT.gov ID

NCT02155270

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Corneal precut 600µm Procedure: Corneal stabincision	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Precut A corneal precut of 600µm will be performed.	Procedure: Corneal precut 600µm
Active Comparator: Stab incision A stab incision without corneal precut will be performed.	Procedure: Corneal stabincision

Arm

Intervention/Treatment

Active Comparator: Precut

A corneal precut of 600µm will be performed.

Procedure: Corneal precut 600µm

Active Comparator: Stab incision

A stab incision without corneal precut will be performed.

Procedure: Corneal stabincision

Outcome Measures

Primary Outcome Measures

Correlation between a wound architecture score and the post-operative astigmatism for the "pre-cut" group and the "stab-incision" group [1 month]

Secondary Outcome Measures

Morphological changes over time [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital	Vienna		Austria	1140

Sponsors and Collaborators

Prim. Prof. Dr. Oliver Findl, MBA

Investigators

Principal Investigator: Oliver Findl, MD, MBA, VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140