NCT06396156

Brief Summary

The Artisan lens (Artisan Aphakic, Ophtec BV) is an iris- claw lens designed for implantation in children with insufficient capsular support. In spite of less surgical manipulations and a relatively shorter operation time, the procedure carries the risk of corneal endothelial cell loss or dis-enclavation, particularly in children. However, most of the studies that studied iris-claw lenses in aphakic children were retrospective evaluated only a single technique; either anterior or retropupillary fixation, or comparable to other techniques of fixation. Thus the aim of this work is to prospectively compare the 2 techniques of iris-claw lens implantation and their effects on central endothelial cell density, the anatomical and visual outcome, as well as the complications' rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

April 29, 2024

Last Update Submit

April 29, 2024

Conditions

Cataracts InfantileSubluxation of LensIntraocular Lens ComplicationCorneal Endothelial Cell Loss

Keywords

aphakiasubluxationcorneal endotheliumiris-claw lens

Outcome Measures

Primary Outcomes (1)

  • Endothelial cell loss

    Percentage of endothelial cell loss from the baseline value

    1 year

Secondary Outcomes (5)

  • Best-corrected visual acuity

    1 year

  • Anterior chamber angle

    1 year

  • Intraocular pressure

    1 year

  • IOL tilt

    1 year

  • IOL decentration

    1 year

Study Arms (2)

anterior chamber iris-claw lens

ACTIVE COMPARATOR

Eyes that receive Artisan IOL that is fixed anterior to the iris

Procedure: Anterior enclavation

Retro-pupillary Iris- Claw lens

ACTIVE COMPARATOR

Eyes that receive Artisan IOL that is fixed posterior to the iris

Procedure: Posterior enclavation

Interventions

Anterior enclavationPROCEDURE

Anterior enclavation of iris-claw lens

anterior chamber iris-claw lens
Posterior enclavationPROCEDURE

Posterior enclavation of iris-claw lens

Retro-pupillary Iris- Claw lens

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Hereditary lens subluxation that requires lensectomy and intraocular lens implantation.
  • Traumatic lens subluxation that requires lensectomy and intraocular lens implantation.
  • Microspherophakia that requires lensectomy and intraocular lens implantati
  • Aphakia with insufficient capsular support.

You may not qualify if:

  • Preoperative central endothelial cell density (CECD) less than 2500 cells/mm2
  • Preoperative anterior chamber depth (ACD) less than 3 mm.
  • Severely damaged iris.
  • History of uveitis or glaucoma.
  • Macular lesions or previous retinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University Pediatric Hospital

Cairo, 11562, Egypt

Location

Cairo University

Cairo, 11562, Egypt

Location

Related Publications (4)

  • Gawdat GI, Taher SG, Salama MM, Ali AA. Evaluation of Artisan aphakic intraocular lens in cases of pediatric aphakia with insufficient capsular support. J AAPOS. 2015 Jun;19(3):242-6. doi: 10.1016/j.jaapos.2015.03.014.

    PMID: 26059670BACKGROUND

  • Yulia DE, Barliana JD, Soeharto DA. Visual outcome of intraocular Iris-Claw lens implantation in Indonesian children with ectopia lentis. Taiwan J Ophthalmol. 2022 Feb 28;13(3):335-340. doi: 10.4103/tjo.tjo_58_21. eCollection 2023 Jul-Sep.

    PMID: 38089522BACKGROUND

  • Cevik SG, Cevik MO, Ozmen AT. Iris-claw intraocular lens implantation in children with ectopia lentis. Arq Bras Oftalmol. 2017 Mar-Apr;80(2):114-117. doi: 10.5935/0004-2749.20170027.

    PMID: 28591285BACKGROUND

  • Yulia DE, Soeharto DA. Efficacy and Safety of Iris-Claw Intraocular Lens in Pediatric Ectopia Lentis: A Literature Review. J Curr Ophthalmol. 2023 Aug 11;35(1):1-10. doi: 10.4103/joco.joco_249_22. eCollection 2023 Jan-Mar.

    PMID: 37680281BACKGROUND

MeSH Terms

Conditions

Lens SubluxationCorneal Endothelial Cell LossAphakiaJoint Dislocations

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesCorneal DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsJoint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • Hatem Saeed, MD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)