ClinicalTrials.gg
Status unknownNCT04904887Updated May 27, 2021

Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

An interventional study of phacoemulsification in Presbyopia, sponsored by Dar Al Shifa Hospital. Status unknown at 1 site in Kuwait. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Dar Al Shifa Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision

Read the detailed description

insertion of new intraocular lens enhanced for intermediate vision

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 40 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Dar Al Shifa Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • normal ocular examination apart from cataract.

Exclusion criteria

Exclusion Criteria:

  • previous ocular surgery.
  • ocular pathology or corneal abnormalities.
  • endothelial cell count below 2000 cells/mm2.
  • corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Assessment of intermediate vision, defocus curve

    Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm. he binocular defocus curve: The binocular defocus curve was done to evaluate the functional range of vision. The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps.

    Procedure: phacoemulsification

Interventions

  • Procedurephacoemulsification

    phacoemulsification with implantation of EYEHANCE IOL

06

What researchers measure

Primary outcomes

  1. intermediate vision assessment

    Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm .

    Time frame: 6 months postoperatively

  2. near vision assessment

    Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm.

    Time frame: 6 months postoperatively

Secondary outcomes

  1. defocus curve

    The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps.

    Time frame: 6 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Daralshifa hospital
    Kuwait, Kuwait
    Recruiting
    • magda torky · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Jul 2021, 8 months after the start.

Of 42 non-industry interventional studies with no phase under Presbyopia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's planned 8 months is below that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2021
First posted
May 27, 2021
StartActual
Nov 1, 2020
Primary completionEst.
Jul 30, 2021
CompletionEst.
Oct 30, 2021
Last update
May 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904887
Lead sponsor
Dar Al Shifa Hospital
Responsible party
magda torky (catract and refractive surgery specialist, Dar Al Shifa Hospital) — Principal investigator
First posted
May 27, 2021
Start date
Nov 1, 2020
Primary completion
Jul 30, 2021 (estimated)
Completion
Oct 30, 2021 (estimated)
Last update
May 27, 2021

Study contacts

Magda Torky
Contact
magda_turkey@yahoo.com
0096594492487

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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