Deep Anterior Lamellar Keratoplasty Versus Penetrating Keratoplasty for Macular Corneal Dystrophy

Deep Anterior Lamellar Keratoplasty Versus Penetrating Keratoplasty for Macular Corneal Dystrophy: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41152132

Enrollment

Registered

2013-02-12

Start date

2006-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Macular corneal dystrophy Eye Diseases Corneal scars and opacities

Interventions

Two different keratoplasty technique: Deep anterior lamellar keratopalsty vs Penetrating keratoplasty.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients aged between 16 and 67 requiring keratoplasty for the treatment of macular corneal dystrophy without endothelial involvement were included.

Exclusion criteria

Exclusion criteria: Patients who were lost to follow-up, had previous eye surgery or who underwent additional surgery combined with keratoplasty were excluded from the data analysis.

Design outcomes

Primary

Measure	Time frame
A complete ophthalmologic examination was performed before the operation and postoperative visit in both groups. The examination included logMAR uncorrected visual acuity (UCVA), logMAR best-corrected visual acuity (BCVA), manifest refraction, slit lamp biomicroscopy, and corneal topographic analysis with the CSO topography system (Costruzione Strumenti Oftalmici, Firenze, Italy). Contrast sensitivity measurements and corneal aberrometric analysis were also performed postoperatively after all sutures were finally removed. The CSV-1OOOE chart (VectorVision, Greenville, Ohio, USA) was used for the assessment of contrast sensitivity. This test consists of four rows of sinewave gratings (3, 6, 12, 18 cycles/degree) that had to be observed by the patient with full correction in place at a distance of 2.5 m. After an initial demonstration, the contrast threshold was measured for each spatial frequency. All patients were tested under both mesopic and photopic conditions and the results were expressed in log units of contrast sensitivity. Corneal aberrometry was recorded and analyzed with the CSO topography system whose software automatically converts the corneal elevation profile into corneal wavefront data using Zernike polynomials with an expansion up to the 7th order. The corneal aberration coefficients and root mean square (RMS) values were calculated for a 6.0 mm pupil. ECD of donor corneas were assessed by a specular microscope before storage in Optisol medium. The endothelium was photographed and evaluated using a Topcon SP 2000p noncontact specular microscope (Topcon Corp., Tokyo, Japan). Images of the central corneal window were reviewed by the same observer (E. S.) and manual correction of the cell borders was performed before final analysis of the endothelium. Twenty endothelial cells were marked for each analysis. For each examination, three measurements of ECD were averaged.	—

Measure

Time frame

A complete ophthalmologic examination was performed before the operation and postoperative visit in both groups. The examination included logMAR uncorrected visual acuity (UCVA), logMAR best-corrected visual acuity (BCVA), manifest refraction, slit lamp biomicroscopy, and corneal topographic analysis with the CSO topography system (Costruzione Strumenti Oftalmici, Firenze, Italy). Contrast sensitivity measurements and corneal aberrometric analysis were also performed postoperatively after all sutures were finally removed. The CSV-1OOOE chart (VectorVision, Greenville, Ohio, USA) was used for the assessment of contrast sensitivity. This test consists of four rows of sinewave gratings (3, 6, 12, 18 cycles/degree) that had to be observed by the patient with full correction in place at a distance of 2.5 m. After an initial demonstration, the contrast threshold was measured for each spatial frequency. All patients were tested under both mesopic and photopic conditions and the results were expressed in log units of contrast sensitivity. Corneal aberrometry was recorded and analyzed with the CSO topography system whose software automatically converts the corneal elevation profile into corneal wavefront data using Zernike polynomials with an expansion up to the 7th order. The corneal aberration coefficients and root mean square (RMS) values were calculated for a 6.0 mm pupil. ECD of donor corneas were assessed by a specular microscope before storage in Optisol medium. The endothelium was photographed and evaluated using a Topcon SP 2000p noncontact specular microscope (Topcon Corp., Tokyo, Japan). Images of the central corneal window were reviewed by the same observer (E. S.) and manual correction of the cell borders was performed before final analysis of the endothelium. Twenty endothelial cells were marked for each analysis. For each examination, three measurements of ECD were averaged.

—

Secondary

Measure	Time frame
Surgical complications	—

Countries

Turkey

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026