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

Cataract Clinical Trial

Official title:

Evaluation of Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients: a Prospective, Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716269
• Other study ID #: 2022756
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Peking University Third Hospital
• Contact: Hong Qi, MD, PhD
• Phone: 13901066889
• Email: doctorqihong[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Hyperopia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Tianjin Eye Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uncorrected distance visual acuity (UCVA)	Uncorrected distance visual acuity (UCVA) of the operated eye will be measured at 5m.	3 months postoperatively
Secondary	Uncorrected intermediate visual acuity	Uncorrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.	3 months postoperatively
Secondary	Uncorrected near visual acuity	Uncorrected near visual acuity of the operated eye will be measured at 40cm.	3 months postoperatively
Secondary	Best corrected intermediate visual acuity	Best corrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.	3 months postoperatively
Secondary	Best corrected near visual acuity	Best corrected near visual acuity of the operated eye will be measured at 40cm.	3 months postoperatively
Secondary	Manifest refraction spherical equivalent	Manifest refraction spherical equivalent of the operated eye will be measured	3 months postoperatively
Secondary	Visual disturbance, spectacle independence and patient satisfaction	A questionnaire including visual disturbance, spectacle independence and patient satisfaction will be distributed to subjects.	3 months postoperatively