CClinicalTrials.gg
Status unknownNCT05716269Updated Feb 8, 2023

Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients

An observational study in Cataract and Hyperopia, sponsored by Peking University Third Hospital. Status unknown. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
45 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

Patients with axial length ≤22.5mm will be recruited. The subjects will undergo bilateral uneventful phacoemulsification and implantation of PanOptix. Visual quality and patients satisfactory will be assessed three months after the surgery.

02

Conditions studied

  • Cataract
  • Hyperopia
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 44 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

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

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Uncorrected distance visual acuity (UCVA)

    Uncorrected distance visual acuity (UCVA) of the operated eye will be measured at 5m.

    Time frame: 3 months postoperatively

  2. Uncorrected intermediate visual acuity

    Uncorrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.

    Time frame: 3 months postoperatively

  3. Uncorrected near visual acuity

    Uncorrected near visual acuity of the operated eye will be measured at 40cm.

    Time frame: 3 months postoperatively

  4. Best corrected intermediate visual acuity

    Best corrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.

    Time frame: 3 months postoperatively

  5. Best corrected near visual acuity

    Best corrected near visual acuity of the operated eye will be measured at 40cm.

    Time frame: 3 months postoperatively

  6. Manifest refraction spherical equivalent

    Manifest refraction spherical equivalent of the operated eye will be measured

    Time frame: 3 months postoperatively

  7. Visual disturbance, spectacle independence and patient satisfaction

    A questionnaire including visual disturbance, spectacle independence and patient satisfaction will be distributed to subjects.

    Time frame: 3 months postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05716269
Lead sponsor
Peking University Third Hospital
Collaborators
Tianjin Eye Hospital
Responsible party
Hong Qi (Professor, Peking University Third Hospital) — Principal investigator
First posted
Feb 8, 2023
Start date
Feb 2023 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Feb 8, 2023

Study contacts

Hong Qi, MD, PhD
Contact
doctorqihong@163.com
13901066889
Hong Qi, MD, PhD
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
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 Feb 2023. You cannot join it, but the record below documents what was studied.

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