NCT05716269

Brief Summary

To evaluate visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 22, 2023

Last Update Submit

February 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Best corrected distance visual acuity of the operated eye

    Best corrected distance visual acuity (BCDVA) of the operated eye will be measured.

    3 months postoperatively

Secondary Outcomes (7)

  • Uncorrected distance visual acuity (UCVA)

    3 months postoperatively

  • Uncorrected intermediate visual acuity

    3 months postoperatively

  • Uncorrected near visual acuity

    3 months postoperatively

  • Best corrected intermediate visual acuity

    3 months postoperatively

  • Best corrected near visual acuity

    3 months postoperatively

  • +2 more secondary outcomes

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hyperopic cataract patients receiving bilateral uneventful phacoemulsification and implantation of PanOptix.

You may qualify if:

  • age-related cataract patients
  • Eye axis length ≤22.5mm and refraction ≥ +0.5D
  • Predicted postoperative corneal astigmatism ≤0.75D
  • mesopic pupil size between 3.0mm to 5.5 mm
  • Preoperative angle kappa ≤ 0.5 mm
  • Preoperative corneal spherical aberration \<0.5μm, high order aberration \<0.5μm

You may not qualify if:

  • In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
  • Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
  • History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis
  • Patients with history of ocular trauma or prior ocular surgery including refractive procedures
  • Preoperative visual acuity of worse than 0.2 logMAR in any eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractHyperopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Hong Qi, MD, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Qi, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02