Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

Keratoconus Clinical Trial

Official title:

Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301598
• Other study ID #: FS-1
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: November 26, 2014
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: The S.N. Fyodorov Eye Microsurgery State Institution
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities

Description:

Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability.

Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed.

All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 52 Years

Eligibility

Inclusion Criteria:

• Advanced keratoconus or stromal corneal scattering

• Normal endothelial cell density

Exclusion Criteria:

• Acute keratoconus in the anamnesis

• Low endothelial cell density

• Age under 18 years

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Opacity
• Keratoconus

Intervention

Procedure:
• FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The S.N. Fyodorov Eye Microsurgery State Institution

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean endothelial cell loss		12 months after surgery	Yes
Primary	Mean postoperative astigmatism		12 months after surgery	No
Primary	UCVA (uncorrected visual acuity)		12 months after surgery	No
Primary	BSCVA (best spectacle-corrected visual acuity)		12 months after surgery	No
Secondary	Corneal hysteresis	Evaluation of biomechanical qualities of the cornea	12 months after surgery	No
Secondary	Corneal resistance factor	Evaluation of biomechanical qualities of the cornea	12 months after surgery	No
Secondary	Central corneal thickness	measured by OCT (optical coherence tomography - Optovue)	12 months after surgery	No
Secondary	Residual recipient's tissue thickness	measured by OCT (optical coherence tomography - Optovue)	12 months after surgery	No