Central Versus Peripheral Air Injection for DALK (Deep Anterior Lamellar Keratoplasty)

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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to create a uniform recipient bed, thereby reducing complications, such as interface irregularity and opacification encountered with conventional lamellar keratoplasty. The big-bubble technique provides a planned, safe, quick and consistent baring of Descemet membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a long learning curve with a low success rate of big-bubble formation and a high rate of DM perforation when performed by surgeons in training. Different modifications to the original technique using intraoperative instruments such as corneal pachymetry, anterior segment optical coherence tomography (OCT), and femtosecond laser, have been used to increase the chances of achieving a successful DM detachment from the deep stroma by air injection. Even with these innovations, the rate of successful big-bubble formation did not reach 100%. Recently, the investigators described a modification to the original big-bubble DALK in which a 27-gauge needle was inserted into the stroma peripherally from the trephination site towards the limbus. The investigators found that air injection peripheral to the trephination can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM). This study was aimed to compare the success rate and complications of big-bubble DALK using central versus peripheral air injection performed by senior cornea fellows under the supervision of an experienced faculty member in an academic hospital.

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Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Central air injection

The needle was moved radially inside the trephination site and advanced to the central or paracentral cornea.

Group Type ACTIVE_COMPARATOR

Central air injection

Intervention Type PROCEDURE

Air was injected inside the trephination site in the central injection group.

Peripheral air injection

The needle was inserted into the deep stroma from the trephination site and advanced into the peripheral cornea to approximately 1.5 mm anterior to the limbus.

Group Type ACTIVE_COMPARATOR

Peripheral air injection

Intervention Type PROCEDURE

Air was injected at the corneal periphery outside the trephination site.

Interventions

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Central air injection

Air was injected inside the trephination site in the central injection group.

Intervention Type PROCEDURE

Peripheral air injection

Air was injected at the corneal periphery outside the trephination site.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate (48 D \< mean keratometry \< 55 D) to advanced (mean keratometry ≥ 55 D or immeasurable keratometry) keratoconus were enrolled.