Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

Cataract Senile Clinical Trial

Official title:

Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266847
• Other study ID #: 20191127
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2020
• Source: Peking University Third Hospital
• Contact: QIanqian Lan
• Phone: +8618607711972
• Email: 54283122[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.

Description:

The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye

• Regular corneal topography and corneal astigmatism = 0.75 Diopter

Exclusion Criteria:

• Pregnant or nursing women

• In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)

• In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)

• Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)

• Patients using systemic or ocular medication that affect visual acuity.

• Patients with history of ocular trauma or prior ocular surgery including refractive procedures

• Patients participating in other clinical trials during the study.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Device:
• monofocal IOL,bifocal IOL,or trifocal IOL
phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	binocular visual acuity	uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast	3 months postoperatively
Secondary	Binocular Contrast sensitivity	Contrast sensitivity measures will be conducted binocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity will be evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree [cpd]). Patients will be allowed 5 minutes to adapt to each illumination level before testing	3 months postoperatively
Secondary	Binocular Defocus Curve	Binocular defocus curves will be obtained in all patients, positioned at 5m under photopic (>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity will be recorded for each type of defocus level. The procedure will be then repeated but with positive lenses. The range of defocus evaluated is from -4.00D to +2.00D.	3 months postoperatively
Secondary	stereopsis	Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.	3 months postoperatively
Secondary	Fusion function	The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.	3 months postoperatively
Secondary	Subjective visual quality	Photic phenomena (score according to severity,0~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.	3 months postoperatively