Clinical evaluation of scleral contact lenses
| ISRCTN | ISRCTN16851376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16851376 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 315747 |
| Protocol serial number | CV22-19 ID22-21, IRAS 315747 |
| Sponsor | CooperVision International Limited |
| Funder | CooperVision |
- Submission date
- 22/06/2022
- Registration date
- 07/07/2022
- Last edited
- 25/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The aim of this study is to find out whether changing to a different type of scleral contact lens (different overall sagittal height) affects contact lens centration.
Who can participate?
Adults who are least 40 years old, who have healthy eyes and who wear multifocal contact lenses.
What does the study involve?
Phase 1 involves two study visits in which participants will be fitted with two different pairs of contact lenses at each visit. Each pair will be worn for about an hour and a half and in this time, video recordings and photos of the lens fit will be taken by a member of the study staff. The second visit will be at least 3 days after the first visit.
Phase 2 will involve participants returning to the clinic to wear a fifth pair of contact lenses and the same routine will be followed - they will wear the contact lenses for about an hour and a half and in this time, video recordings and photos of the lens fit will be taken by a member of the study staff.
What are the possible benefits and risks of participating?
The participants are current contact lens wearers and they will use three currently marketed contact lenses under the control of the investigator. The risks to the participant are no greater than wearing their own contact lenses. The risks will be further minimised by the fact that the contact lenses will only be worn in the clinic under the supervision of the investigators. The possible benefit to the participant will be to try different contact lenses with different levels of comfort that they could eventually purchase from their own practitioner.
Where is the study run from?
Ocular Technology Group - International (UK)
When is the study starting and how long is it expected to run for?
June 2022 to March 2023
Who is funding the study?
CooperVision International Limited (UK)
Who is the main contact?
Deborah Moore, dmoore@otg.co.uk
Contact information
Public
Lower Ground Floor
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre non-randomized sequential study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Non-dispensing clinical evaluation of customised OneFit MED scleral contact lenses |
| Study objectives | The primary hypothesis to be tested will be that changing the scleral contact lens overall sagittal height will affect contact lens centration. |
| Ethics approval(s) | Approved 23/05/2022, South Central - Oxford A Research Ethics Committee (Ground Floor, Temple Quay House, 2 the Square, Bristol, BS1 6PN, UK; +44 (0)2071048290; oxforda.rec@hra.nhs.uk), ref: 22/SC/0171 |
| Health condition(s) or problem(s) studied | Presbyopia |
| Intervention | Each participant will wear all the study contact lenses in a sequential fashion for about 1 hour and a half each. During each period of wear, contact lens fitting video recordings and photos will be taken. These will then be analysed post hoc. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | OneFit MED Scleral Lens |
| Primary outcome measure(s) |
Contact lens centration in primary and down gaze measured in mm after 40 minutes of wear |
| Key secondary outcome measure(s) |
Corneal clearance measured in mm after 40 minutes of wear |
| Completion date | 01/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. 40 or more years of age 2. Have read and understood the Participant Information Sheet in English 3. Have read, signed and dated the Informed Consent 4. Current multifocal contact lens wearer 5. Spectacle refraction: 5.1. Distance: Sphere: -6.00D to + 4.00DS 5.2. Astigmatism: -0.00DC to -1.50DC in each eye 5.3. Near Addition: +0.75D to +2.50D 6. Best corrected visual acuity of at least 20/25 in each eye 7. Have normal eyes with the exception of the need for visual correction 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals |
| Date of first enrolment | 06/07/2022 |
| Date of final enrolment | 01/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SW1E 6AU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | version 1.0 | 24/04/2023 | 25/04/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISCRTN16851376 BasicResults V1.0 24.04.23.pdf
- Basic results
Editorial Notes
25/04/2023: The basic results have been uploaded as an additional file.
05/07/2022: Trial's existence confirmed by the South Central - Oxford A Research Ethics Committee.
