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

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Central air injection
Peripheral air injection
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring deep anterior lamellar keratoplasty, big-bubble technique, peripheral air injection, keratoconus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • History of ocular surgery, concomitant ocular pathologies, such as vernal keratoconjunctivitis, cataract, glaucoma, and retinal abnormalities.

Sites / Locations

  • Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Central air injection

Peripheral air injection

Arm Description

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

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.

Outcomes

Primary Outcome Measures

The rate of successful big-bubble formation

Secondary Outcome Measures

Full Information

First Posted
June 13, 2015
Last Updated
April 19, 2016
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02485951
Brief Title
Central Versus Peripheral Air Injection for DALK (Deep Anterior Lamellar Keratoplasty)
Official Title
Big-bubble Deep Anterior Lamellar Keratoplasty: Central Versus Peripheral Air Injection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
deep anterior lamellar keratoplasty, big-bubble technique, peripheral air injection, keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Central air injection
Arm Type
Active Comparator
Arm Description
The needle was moved radially inside the trephination site and advanced to the central or paracentral cornea.
Arm Title
Peripheral air injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Central air injection
Intervention Description
Air was injected inside the trephination site in the central injection group.
Intervention Type
Procedure
Intervention Name(s)
Peripheral air injection
Intervention Description
Air was injected at the corneal periphery outside the trephination site.
Primary Outcome Measure Information:
Title
The rate of successful big-bubble formation
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with moderate (48 D < mean keratometry < 55 D) to advanced (mean keratometry ≥ 55 D or immeasurable keratometry) keratoconus were enrolled. Exclusion Criteria: History of ocular surgery, concomitant ocular pathologies, such as vernal keratoconjunctivitis, cataract, glaucoma, and retinal abnormalities.
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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