High myopia macular hole retinal detachment
Conditions
Interventions
Experimental group:Vitrectomy combined with lens capsule flap transplantation
Control group:Vitrectomy combined with internal limiting membrane packing
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients >= 50 years old diagnosed as HMMHRD by indirect ophthalmoscopy, macular OCT, B-ultrasound of both eyes and appendages, and fundus photography after mydriasis; 2. Equivalent spherical lens diopter = 26mm; 3. MH is the main cause of RD; 4. The lens is turbid, which needs to be combined with cataract surgery, and there is no obvious calcification in the lens capsule; 5. The range of RD is within the retinal vascular arch of the posterior pole; 6. Agree to receive surgical treatment and sign relevant informed consent.
Exclusion criteria
Exclusion criteria: 1. RD patients with other types of holes except MH, choroidal detachment, obvious proliferative vitreoretinopathy, intraocular hemorrhage, severe cataract, glaucoma, retinal vascular inflammation or obstruction, macular degeneration, HM patients with other serious visual diseases (macular neovascularization, macular hemorrhage, pathological myopia, macular atrophy, etc.); 2. Patients with previous history of intraocular surgery (PPV, intravitreal drug injection, etc.); 3. Patients whose general condition cannot tolerate the operation; 4. Patients who cannot cooperate with the examination and follow-up for less than 6 months; 5. Unwilling to undergo one-stage combined cataract surgery; 6. Researchers believe that if we continue to participate in this study, we may cause the subjects to face greater risks of diseases or conditions (such as grade 3 hypertension, AIDS, malignant tumors, severe mental, cardiovascular, nervous, respiratory, digestive and other systemic diseases, or long-term use of stimulating hormone, immunodeficiency diseases, cardiac stenting, organ transplantation and so on); 7. Diabetic patients with poor glycemic control; 8. Patients with poor communication skills and compliance; 9. Patients without the ability to follow the postoperative position; 10. Participation in other trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type I closure rate of macular hole at 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Type I closure rate of macular hole at 3 months after operation;Type II closure rate of macular hole at 6 months after operation;Type II closure rate of macular hole at 3 months after operation;Changes of BCVA compared with baseline visual acuity 6 months after operation;Changes of BCVA compared with baseline visual acuity 3 months after operation;Changes of P1 wave response density in macular region compared with baseline 6 months after operation;Changes of P1 wave response density in macular region compared with baseline 3 months after operation;Changes of macular retinal sensitivity compared with baseline 6 months after operation;Changes of macular retinal sensitivity compared with baseline 3 months after operation;Number of adverse events and reactions; | — |
Countries
China
Contacts
Public ContactTianwei Qian
Shanghai General Hospital
Outcome results
None listed