Irregular AstigmatismNCT04987060
Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (New Approach)
A study testing Intrastromal Fresh Human Lenticule Implantation in people with Irregular Astigmatism, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial summary
The aim of the study is to present the effect of implanting intrastromal fresh corneal lenticule by SMILE surgery as a new method-approach to correct the corneal shape on purpose to reduce irregular astigmatism and increasing visual acuity after penetrating keratoplasty. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Irregular Astigmatism
- What is being tested?
- Intrastromal Fresh Human Lenticule Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Mar 2017to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with irregular astigmatism
- low visual acuity
Who cannot join
- history of glaucoma
- retinal detachment
- history of ocular inflamation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to present the effect of implanting intrastromal fresh corneal lenticule by SMILE surgery as a new method-approach to correct the corneal shape on purpose to reduce irregular astigmatism and increasing visual acuity after penetrating keratoplasty.
Read the detailed description
Irregular astigmatism occurs when the curvature of the eye is pronounced in any direction, not just the center. The curve could be steeper towards the bottom than on top, or it could be any configuration in which the eye's surface area is uneven.
Irregular astigmatism usually can result from corneal degenerations(keratoconus,pellucid marginal degeneration,keratoglobus), corneal surgery or trauma.
Irregular astigmatism is still the main cause of decreased visual acuity after penetrating keratoplasty.
Our study present new therapeutic method and new technology to manage irregular astigmatism after PK. Knowing that the incidence of high and irregular astigmatism after PK is still a frequent complication and source of frustration for patients and corneal surgeons our study present an adequate surgical technique implanting intrastromal human corneal lenticule using SMILE for treatment of corneal irregular astigmatism after PK trying satisfy patients visual expectations.
- Conditions
- Irregular Astigmatism
- Being tested
- Intrastromal Fresh Human Lenticule Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal Fresh Human Lenticule ImplantationDevice
The stromal pocket diameter was set 8.0 mm and cap thickness was set to 140 μm from corneal surface and a 2mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 2 mm superior incision. Incision position changed according to the position of the highest K values.
| Study group | Role | What they receive |
|---|---|---|
| Intrastromal Fresh Human Lenticule Implantation | Other | The aim of this study is to investigate the effect of intrastromal fresh corneal lenticule implantation using Smile module surgery after PK with primary objective to increase visual acuity by reducing irregular astigmatism according to high K values. The stromal pocket diameter was 8 mm, 2mm super incision, 140-µm cap thickness and fresh lenticular implantation is performed. Receives: Device: Intrastromal Fresh Human Lenticule Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of visual acuity
Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.
Measured: 12 months
Secondary outcomes (1)
Decrease of irregular astigmatism
In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Mar 2017
- Primary completion1 Mar 2021
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irregular AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Irregular astigmatism group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Hospital Pristina Kosovo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987060
- Sponsor's protocol ID
- EyeHPristina2
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided