Condition category
Eye Diseases
Date applied
04/03/2017
Date assigned
14/03/2017
Last edited
13/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Prof Paolo Lanzetta

ORCID ID

http://orcid.org/0000-0003-3746-141X

Contact details

Istituto Europeo di Microchirurgia Oculare
via Fiducio 8
Udine
33100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

I-2014A27

Study information

Scientific title

In patients with presbyopia and hypermetropia, do optimal keratoplasty improve near and distance visual acuity?

Acronym

Study hypothesis

Optimal keratoplasty is safe and effective for the correction of hyperopia and presbyopia.

Ethics approval

Istituto Europeo di Microchirurgia Oculare (IEMO) Institutional Review Board, 22/03/2014, ref: I-2014A27

Study design

Single-centre single-arm non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2014

Overall trial end date

01/06/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35

Participant 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

Recruitment start date

01/07/2014

Recruitment end date

01/05/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Istituto Europeo di Microchirurgia Oculare
via Fiducio 8
Udine
33100
Italy

Sponsor information

Organisation

Istituto Europeo di Microchirurgia Oculare

Sponsor details

via Fiducio 8
Udine
33100
Italy

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Istituto Europeo di Microchirurgia Oculare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

31/08/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes