anisometropia
Conditions
Interventions
Scleral lens treatment group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for anisometropia or anisometropic amblyopia and have poor results with conventional treatment; (2) Have irregular astigmatism or regular astigmatism, and the back vertex power range of the expected scleral contact lens is from -30.00D to +30.00D (including both ends); (3) The best corrected distance visual acuity with spectacle is better than the uncorrected distance visual acuity; (4) Be able to understand the purpose of the trial, have been fitted with scleral lenses, and the subject himself or his legal guardian has signed the informed consent form and can complete the follow-up on time.
Exclusion criteria
Exclusion criteria: If either eye of the subject meets any of the following exclusion criteria, the subject cannot be enrolled in this trial: (1) There is an active infectious lesion in the eye; (2) Suffering from a systemic disease that causes low immunity or may affect the wearer of rigid contact lenses. (3) Have a history of allergy to contact lenses or contact lens care solutions; (4) There is an active allergic reaction on the ocular surface and ocular appendages, or it may be aggravated by wearing lenses or using lens care solutions; (5) The living or working environment is not suitable for wearing contact lenses, such as environments with diffuse dust, drugs, aerosols, dust, etc. in the air, or long-term exposure to windy and sandy, highly polluted environments, and environments with contact chemical gases; (6) Those who have stopped wearing soft contact lenses for less than 1 week, rigid gas permeable corneal contact lenses (RGP) for less than 2 weeks, and orthokeratology lenses for less than 30 days; (7) Those who have difficulty in fitting trial lenses; (8) Those with excessive sensitivity and high expectations, or those with severe psychological and mental diseases such as anxiety and depression; (9) Pregnant and lactating women, or those who plan to become pregnant in the near future; (10) Other situations where the investigator judges that the subject is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scleral lens corrected distant visual acuity;Best corrected distant visual acuity with scleral lens;Condition of cornea and conjunctiva; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected distant visual acuity;Best corrected distant visual acuity;Diopter without wearing scleral lens;Diopter when wearing scleral lens;Visual function score (NEI-VFP-25 scale); | — |
Countries
China
Contacts
Public ContactZhang Yan
Shanghai General Hospital
Outcome results
None listed