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Correlation Between Sulcus Anatomy and Other Parameters After Horizontal & Vertical Intraocular Lens (IOLs) Placements

NCT04208633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-12-23

No results posted yet for this study

Summary

Usually following cataract surgery patients would expect to have normal distance vision and not require the use of distance glasses. However, in clinical practice desired vision post cataract surgery is not achieved sometimes. In such cases a piggyback lens is used to enhance the visual outcome. This lens is placed in the ciliary sulcus (space between the iris and the lens). Often this piggyback lens is not the best fit for the ciliary sulcus space and it moves. This study will be using ultrasound biomicroscopy to measure the ciliary sulcus dimensions pre and postoperatively to estimate the normal anatomy and it's variations. Patients in this study will be randomised as to which way the intraocular lens is placed in the eye (horizontally or vertically) at the time of their cataract surgery. Patients requiring cataract surgery in both eyes will be identified from the Eye Hospital at the Royal Sussex County Hospital. Patients will be in the study for up to 6 months from being identified as suitable through to the operation in the 2nd eye and a final study visit.

Conditions

  • Cataract
  • Pseudophakia

Interventions

PROCEDURE

Horizontal placement of the intraocular lens in the capsular bag

The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL.

PROCEDURE

Vertical placement of the intraocular lens in the capsular bag

The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL.

Sponsors & Collaborators

  • Brighton and Sussex University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Mayank Nanavaty · Brighton and Sussex University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2019-01-05
Completion
2019-01-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04208633 on ClinicalTrials.gov