The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.

Study Overview

• Status: Completed
• Conditions: Microspherophakia

• Study Type: Observational
• Enrollment (Actual): 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A retrospective study was conducted on 9 patients (18 eyes) diagnosed with microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine from July 2016 to April 2020.

Description

Inclusion Criteria:

• Microspherophakia was diagnosed and lens diameter<9mm;
• The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
• Lens dislocated into the anterior chamber;
• Lens dislocation caused elevated intraocular pressure (IOP);
• The lens contacted the corneal endothelium;
• Cataract;
• Corneal endothelial cell density>1000/mm2;
• The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；
• There was possible improvement in postoperative visual acuity measured by retinometer.

Exclusion Criteria:

• The lens is centered and the position of the lens is stable;
• Glasses can correct the vision obviously;
• The reason for the elevated IOP was independent with the lens;
• A high possibility of corneal decompensation after surgery;
• Fundus function was poor and it is not expected to improve the vision after surgery;
• Combined with other ocular diseases which were not suitable for IOL implantation;
• Combined with a systemic disease that the patient cannot tolerate the surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Microspherophakia; This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	6 month postoperation
Visual function	uncorrected distance visual acuity (UDVA) measured using a decimal chart	6 month postoperation
Intraocular pressure	intraocular pressure measured using non-contact tonometer	6 month postoperation
PCIOL tilt degree	PCIOL tilt degree measured using Ultrasound biomicroscope	6 month postoperation
PCIOL decentration distance	PCIOL decentration distance measured using Ultrasound biomicroscope	6 month postoperation
Endothelial cell density	Endothelial cell density was measured by specular microscopy	6 month postoperation
Anterior chamber depth	Anterior chamber depth measured using Ultrasound biomicroscope	6 month postoperation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 28, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Lens Diseases; Lens Subluxation; Glaucoma; Corneal Diseases; Ectopia Lentis
• Other Study ID Numbers: xuwen2020-465

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No