Clinical trial NCT05716269: Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients
Official title: Evaluation of Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients: a Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Hyperopia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Eye Hospital
First posted: 2023-02-08
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hyperopic cataract patients receiving bilateral uneventful phacoemulsification and implantation of PanOptix.

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

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Best corrected distance visual acuity of the operated eye
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Uncorrected distance visual acuity (UCVA)
timeFrame: 3 months postoperatively
measure: Uncorrected intermediate visual acuity
timeFrame: 3 months postoperatively
measure: Uncorrected near visual acuity
timeFrame: 3 months postoperatively
measure: Best corrected intermediate visual acuity
timeFrame: 3 months postoperatively
measure: Best corrected near visual acuity
timeFrame: 3 months postoperatively
measure: Manifest refraction spherical equivalent
timeFrame: 3 months postoperatively
measure: Visual disturbance, spectacle independence and patient satisfaction
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: