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A multi-center, randomized, open, parallel control clinical trials of the foldable intraocular lens (suming) that is used in cataract extraction for aphakia vision correction

Spherical foldable intraocular lens

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013943
Enrollment
Unknown
Registered
2017-12-15
Start date
2017-01-06
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cataract

Interventions

Sponsors

Beijing Tongren Hospital, CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old male and female; 2. The monocular or binocular with cataracts, and plans for cataract ultrasonic emulsification, excision plus intraocular lens (iol) implantation in nuclear hardness of 1 ~ 4 (for both eyes cataract patients and nuclear hardness are within the scope of the 1 ~ 4, such as the eyes of nuclear hardness is the same, customize a eye into the group of the test; If the hardness of the binocular nuclei is different, the heavier one is selected for the eye into the test; 3. Expected intraocular lens correction of diopter in -5d to 30D; 4. Preoperative eye correction of distant vision is less than 20/40; 5. Preoperative corneal endothelial cell count is greater than 2000 / mm2; 6. Preoperative eye pupil diameter was 2.5mm ~ 4mm; 7. Preoperative room depth was greater than 2.00 mm; 8. Preoperative ocular axial length was 21 mm ~ 28 mm; 9. Preoperative astigmatism was no more than 2.0d; 10. Voluntary participation in this clinical trial and signing informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with implantation of intraocular lens contraindications, such as small eyeballs, glaucoma, severe corneal malnutrition, obvious macular/pigment epithelial cell lesions, and diabetic video network Membranous lesions, severe optic nerve atrophy, severe anterior chamber, choroid hemorrhage, large number of vitreous loss, uncontrolled intraocular pressure, chronic uveitis, and later Cystic rupture or ciliary small band separation (cannot be fixed in the lens), vitreous hemorrhage or severe turbidity, crystal dislocation or semi-dislocation, and other serious eyes that accompany hair; 2. Combined with ocular infectious diseases, such as chronic dacryocystitis; 3. Severe corneal disease; 4. Corneal injury or corneal scar; 5. Have retinal detachment or retinopathy; 6. Have had an ocular injury within 3 months; 7. Have received intraocular or corneal surgery; 8. Severe dry eye or meibomian gland dysfunction (MGD); 9. Traumatic cataract or congenital cataract; 10. With the addition of cataract, the disease or condition that severely affects the vision, the optimal correction of the distant vision can not reach 20/40; 11. The researchers determined that the lateral eye amblyopia or blindness function; 12. Eye joint operation is required; 13. Eye or systemic drugs that may be used during or during the study may affect visual or postoperative judgment; 14. With serious or unstable heart, liver, kidney, lung, endocrine (including incomplete thyroid function), blood, mental illness and other diseases that seriously affect the operation; 15. Diabetes mellitus (> 8 mmol/L), or a history of diabetes mellitus with the onset of eye disease or condition affecting the vision after surgery; 16. An electrocardiogram or laboratory test results suggest surgical contraindications; 17. Allergy to equipment or drugs used in research; 18. Pregnant and lactating women; 19. Unsupervised or not able to follow the advice of the physician; 20. To participate in the clinical trial of other drugs or medical devices within 3 months before screening; 21. The investigator's judgment was not appropriate for other situations in which the trial was conducted.

Design outcomes

Primary

MeasureTime frame
At 6 months after surgery, the percentage of the best Best correction of distant vision at or above 20/40;

Countries

China

Contacts

Public ContactNingli Wang

Beijing Tongren Hospital, CMU

wningli@vip.163.com+86 13511026669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026