Retinopathy of prematurity
Conditions
Interventions
Group 1:laser treatment
Group 2:intraocular injection Lucentis
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) According to the international classification, the clinical diagnosis of the patient is clearly pre-threshold type 1 ROP (including 2+/3+ in area II) and threshold ROP in zone II; (2) The patient has not received any eye disease treatment before enrollment; (3) The patient's general condition is good and can tolerate ophthalmic treatment; (4) The patients guardian voluntarily participates in this clinical trial and signs an informed consent form; (5) The patient's guardian has the willingness to follow-up and can follow-up at the prescribed time.
Exclusion criteria
Exclusion criteria: 1. The patient's clinical diagnosis is unclear; 2. Ocular diseases that may interfere with the interpretation of the study results during the screening or baseline visits: various types of retinopathy with similar clinical manifestations, such as familial exudative retinopathy, pigment incontinence-related retinopathy, etc.; Optical interstitial opacity affects the observation of fundus lesions, such as corneal lesions, cataracts, permanent primordial vitreous hyperplasia, etc.; any active eye or eye infections or inflammations (for example, blepharitis, conjunctivitis, cornea) that exist at screening or at baseline Inflammation, scleritis, uveitis, endophthalmitis); 3. Uncontrolled glaucoma at screening or at baseline (intraocular pressure [IOP] >=30 mmHg when receiving drug treatment, or according to the judgment of the investigator); 4. The patient suffers from other systemic diseases, such as severe heart, lung, liver, and renal insufficiency, or other systemic basic diseases that are severely assessed as not suitable for participating in the research; 5. The patient has participated in other clinical trials or received retinopathy drug treatment before enrollment, such as: previously received the following treatments: (1) anti-angiogenesis drugs (pegaptanib (Macugen), bevacizumab (Avastin)), VEGF-Trap, KH902; (2) anecortave acetate, corticosteroids; (3) protein kinase C inhibitor, small interfering nucleic acid (siRNA); 6. The current or planned systemic use of drugs known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil?), tamoxifen, phenothiazines and ethambutol; 7. Patient has previously received laser photocoagulation, vitrectomy, or any other intraocular surgery; 8. The family members of the patient refuse to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation;Measurement of eyeball biological parameters of premature infants and infants;Macular development assessment;Evaluation of retinal function;Evaluation of retinal vascular development;Visual function assessment;Intraocular pressure evaluation;The incidence of intraoperative and postoperative complications; | — |
Countries
China
Contacts
Public ContactPeiquan Zhao
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed