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

NCT04208633 | Completed DMC

• 1 other identifier: 145273
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cataract; pseudophakia; intraocular lens; ciliary sulcus; anatomy

Outcome Measures

Primary Outcomes (1)

• Sulcus diameter versus anterior chamber dimension

  Correlations between sulcus diameter and anterior chamber dimensions in the 4 axes pre and post operatively and also for the differences post and pre operatively.

  1 month

Secondary Outcomes (5)

• Changes in sulcus diameter in 4 axes in eyes with vertical and horizontal placement of IOLs

  1 month

• Changes in anterior chamber depth following cataract extraction

  1 month

• Changes in anterior chamber diameter following cataract extraction

  1 month

• Rotation of the IOL in degrees from it's primary placement at 4-6 weeks at postoperative follow up.

  1 month

• To explore any relationship between demographics in relation to sulcus anatomy

  1 month

Study Arms (2)

Horizontal placement of the intraocular lens

OTHER

The eyes randomised to have horizontal placement of intraocular lenses

Procedure: Horizontal placement of the intraocular lens in the capsular bag

Vertical placement of the intraocular lens

OTHER

Fellow eye receiving vertical placement of intraocular lens.

Procedure: Vertical placement of the intraocular lens in the capsular bag

Interventions

Horizontal placement of the intraocular lens in the capsular bag PROCEDURE

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.

Horizontal placement of the intraocular lens

Vertical placement of the intraocular lens in the capsular bag PROCEDURE

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.

Vertical placement of the intraocular lens

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cataracts undergoing cataract extraction in both eye.
• Diopters of corneal astigmatism Scheimpflug imaging (Pentacam HR, Oculus, Germany)

You may not qualify if:

• Less than 18 years
• Significant ophthalmic co-morbidity that may affect the anatomy of the eye
• Not competent to give fully informed consent
• Unable to have surgery and attend follow up appointment at Sussex Eye Hospital, Brighton

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (1)

Brighton & Sussex University Hospitals NHS Trust

Brighton, Sussex, BN2 5BF, United Kingdom

Location

Related Publications (1)

• Nanavaty MA, Offer C, Kier C, Way C, Frattaroli P, Bremner S. Changes in the sulcus and anterior chamber after horizontal or vertical intraocular lens orientation: prospective randomized study. J Cataract Refract Surg. 2025 Nov 1;51(11):1011-1018. doi: 10.1097/j.jcrs.0000000000001727.

  PMID: 40601404 DERIVED

Related Links

• Health Research Authority UK

MeSH Terms

Conditions

Cataract; Pseudophakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mayank Nanavaty

  Brighton and Sussex University Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fellow eye comparison when one eye has the intraocular lens placed in horizontal and other in vertical axis.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 23, 2019
• Study Start: September 14, 2016
• Primary Completion: January 5, 2019
• Study Completion: January 5, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)