Optimal keratoplasty for the correction of presbyopia and hypermetropia
| ISRCTN | ISRCTN22899379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22899379 |
| Secondary identifying numbers | I-2014A27 |
- Submission date
- 04/03/2017
- Registration date
- 14/03/2017
- Last edited
- 15/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Presbyopia is a condition associated with aging of the eye that leads to s progressively worsening ability to focus clearly on close objects. In a younger person, the lens is soft and flexible so it can easily reshape the lens to focus on close and distant objects. With age, the lens becomes harder so it is unable to reshape as easily. Hyperopia, also known as farsightedness, is another forma of presbyopia which makes it difficult for people to focus on things that are close. Optimal keratoplasty is a new form of laser eye treatment to treat presbyopia. It works by remodeling the shape of the cornea (transparent layer forming the front of the eye) to help sharpen distance vision and near vision. The aim of this study is to investigate the safety and effectiveness of optimal keratoplasty in correcting hyperopia (long-sightedness) and presbyopia.
Who can participate?
Adults aged 40 years and over who have hyperopia and presbyopia
What does the study involve?
All participants receive optimal keratoplasty, which involves having a special laser applied to their eyes while they are lying down. The procedure takes around 10-15 minutes altogether. Before the procedure and then one hour, one day, one week and one, three and six months after the procedure, participants have an eye test in order to find out if there has been any improvement to their vision.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their eyesight. There is a small risk that some participants may experience minor vision problems for a short time after the procedure, such as glare (light entering the eye and interfering with vision) and halos (bright circles that surround a light source).
Where is the study run from?
Istituto Europeo di Microchirurgia Oculare (Italy)
When is the study starting and how long is it expected to run for?
June 2014 to June 2016
Who is funding the study?
Istituto Europeo di Microchirurgia Oculare (Italy)
Who is the main contact?
Professor Paolo Lanzetta
Contact information
Public
Istituto Europeo di Microchirurgia Oculare
via Fiducio 8
Udine
33100
Italy
 ORCID ID |
0000-0003-3746-141X |
|---|
Study information
| Study design | Single-centre single-arm non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | In patients with presbyopia and hypermetropia, do optimal keratoplasty improve near and distance visual acuity? |
| Study objectives | Optimal keratoplasty is safe and effective for the correction of hyperopia and presbyopia. |
| Ethics approval(s) | Istituto Europeo di Microchirurgia Oculare (IEMO) Institutional Review Board, 22/03/2014, ref: I-2014A27 |
| Health condition(s) or problem(s) studied | Presbyopia and hypermetropia |
| Intervention | All patients undergo laser irradiation of the corneal tissue using the NTK Optimal Keratoplasty (Opti-K) System. While the patient is lying in a supine position, an output beam is directed onto the cornea in a symmetrical square ring pattern (6 and 7.2 mm diameter), so that the corneal epithelium is protected from thermal damage with a sapphire application window/suction ring. Thereafter, laser is applied at 1.93 μm wavelength. The laser is typically operated with a total delivered power of 0.80-1.28 W for a period of 150 ms. The duration of the entire procedure is approximately 10-15 minutes. Patients are evaluated at baseline, 1 hour, 1 day, 1 week, 1 month, 3, and 6 months after treatment. The duration of a visit is about an hour. Baseline and follow-up examinations include measurement of uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), CDVA, manifest refraction, corrected near visual acuity (CNVA), presbyopic add, corneal optical coherence tomography (OCT), corneal pachymetry, slit lamp examination of the anterior segment, and dilated fundus examination. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Mean uncorrected near visual acuity is measured by ETDRS charts and standardized procedures at baseline and 6 months. |
| Secondary outcome measures | Uncorrected distance visual acuity in hypemetropic/presbyopic eyes is measured by ETDRS charts and standardized procedures at baseline and 6 months. |
| Overall study start date | 01/06/2014 |
| Completion date | 01/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 35 |
| Key inclusion criteria | 1. Aged 40 years and over 2. Low to moderate hypermetropia (manifest refraction: sphere between +1 to +2.5 D, absolute cylinder ≤1 D) or presbyopia (with presbyopic adds between +1D to +2.75 D) 3. Documented stable refraction 4. Corrected distance visual acuity (CDVA) of 33 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or better |
| Key exclusion criteria | 1. Nystagmus 2. Corneal diameter ≤9 mm 3. Central corneal thickness ≤500 μm 4. Dry eye disease 5. Severe blepharitis 6. Residual, recurrent or active corneal disease or abnormality |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 01/05/2016 |
Locations
Countries of recruitment
- Italy
Study participating centre
Udine
33100
Italy
Sponsor information
Other
via Fiducio 8
Udine
33100
Italy
"ROR" |
https://ror.org/02t9kcf24 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/08/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a Medline indexed peer reviewed journal. |
| IPD sharing plan | Participant level data are stored as medical charts at the center. Charts are anonymised with a numeric code. Patients signed an informed consent allowing data storage. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/04/2017 | 15/02/2022 | Yes | No |
Editorial Notes
15/02/2022: Publication reference added.
