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Clinical Trials/NCT07257172
NCT07257172RecruitingNot Applicable

Sutureless Technique for Repositioning and Scleral Fixation of the Capsular Bag - Intraocular Lens Complex With Permanent Use of Iris Retractors

Military Institute od Medicine National Research Institute2 sites in 1 country40 target enrollmentStarted: May 28, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
BCVA

Study Overview

Brief Summary

Sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors

Detailed Description

Purpose of the study is to present results of sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens (IOL) complex in the surgical treatment of subluxated lenses. The investigators rated the BCVA, refractive outcomes, intraocular pressure, , tilt and decentration, and also determined intra- and postoperative complications.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • only adult men and women with subluxation lens

Exclusion Criteria

  • previous ocular surgery
  • Fuchs' dystrophy
  • corneal haze or scarring
  • history of corneal transplantation
  • clinically active uveitis
  • advanced glaucoma
  • macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)

Outcomes

Primary Outcomes

BCVA

Time Frame: before and 12 months after surgery

The change of best- corrected visual acuity

RE

Time Frame: 12 months after surgery

Postoperative total refractive error

Position IOL

Time Frame: 1 month and 12 months after surgery

Tilt and decentration IOL

Secondary Outcomes

  • Number of complications(from day 1 until 12 months after surgery)

Investigators

Sponsor
Military Institute od Medicine National Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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