Subluxation of Lens, Surgical Instruments，Cataract
Conditions
Brief summary
To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.
Interventions
DEVICEMultifunctional Cataract-assisted Retractor
Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of lens subluxation. * Patients need to undergo lens subluxation surgery
Exclusion criteria
* Active intraocular inflammation * The intraocular pressure (IOP) was higher than 25 mmHg * The endothelial cell count (ECC) was less than 1,200 cells/mm2 * Combined with other eye diseases * Combined with other serious systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success rate | through study completion, an average of 1 year | Surgical success rate of operation with different retractor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful implantation rate of intraocular lens | through study completion, an average of 1 year | implantation rate of intraocular lens with different retractor |
| Visual function | 1day postoperation，1 week，1 month， 3month postoperation | Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart |
| intraocular pressure | 1 day, 1 week, 1 month, and 3 month postoperation | intraocular pressure |
| endothelial cell count | 1 week, 1 month, and 3 month postoperation | endothelial cell count |
Countries
China
Outcome results
None listed